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Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS) (PATHOS)

Primary Purpose

Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cisplatin
Postoperative radiotherapy
Sponsored by
Lisette Nixon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer focused on measuring Human papillomavirus HPV positive oropharyngeal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed or suspected squamous cell carcinoma of the oropharynx.
  • UICC/AJCC TNM 7th edition stage T1-T3, N0-N2b (or UICC TNM 8th edition stage T1-T3, N0-N1) disease.
  • Multidisciplinary team (MDT) decision to treat with primary transoral resection and neck dissection.
  • Patients considered fit for surgery and adjuvant radiotherapy
  • Aged 18 or over.
  • Written informed consent provided.

Exclusion Criteria:

  • Known HPV negative squamous cell carcinomas of the head and neck: A negative result for p16 Immunohistochemistry automatically excludes a patient from the trial. If initial p16 testing is positive but High Risk HPV (HR HPV) In-Situ Hybridization (ISH)/Polymerase Chain Reaction (PCR) does not demonstrate the presence of HR HPV DNA, the patient will also be excluded. Patients who are p16+ may complete swallowing assessments, excluding videofluoroscopy, and surgery whilst HR HPV DNA status is being determined (with recourse to central concordance testing, if appropriate, for UK centres). HPV positivity, as determined by p16 and the demonstration of HR HPV DNA is essential before patients undergo videofluoroscopy or randomisation.
  • T4 and/or T1-T3 tumours where transoral surgery is considered not feasible.
  • UICC/AJCC TNM 7th edition N2c-N3 nodal disease (or UICC/AJCC TNM 8th edition N2-N3 nodal disease).
  • Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
  • Current smokers with clinically staged N2b disease (including smokers up to 6 months before diagnosis), even if HPV-positive. Vaping is permitted and should be considered as non-smoking status.
  • Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer.
  • Patients with distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g., CT thorax and upper abdomen or PET-CT.
  • Patients with a history of malignancy in the last 5 years, except basal cell carcinoma of the skin or carcinoma in-situ of the cervix.
  • Women who are pregnant or breastfeeding and fertile women who will not be using contraception during the trial.

Sites / Locations

  • Board of Trustees of the Leland Stanford Junior UniversityRecruiting
  • Advent HealthRecruiting
  • MD Anderson Cancer Centre
  • Metro South HealthRecruiting
  • UnicancerRecruiting
  • Vivantes KlinikumRecruiting
  • Asklepios KlinikenRecruiting
  • Universitat LeipzigRecruiting
  • Ernst von Bergmann KlinikumRecruiting
  • Städtisches Klinikum SolingenRecruiting
  • Universitätsklinikum UlmRecruiting
  • University Hospitals Dorset NHS FoundationRecruiting
  • Royal United Hospitals Bath NHS Foundation TrustRecruiting
  • Queen Elizabeth HospitalRecruiting
  • Royal Blackburn HospitalRecruiting
  • Royal Sussex County HospitalRecruiting
  • University Hospitals Bristol NHS Foundation TrustRecruiting
  • Cambridge University Hospitals NHS Foundation TrustRecruiting
  • Kent and Canterbury HospitalRecruiting
  • HPV Research Group Section of Pathology Cardiff University ,School of Medicine
  • Cardiff and Vale University Local Health BoardRecruiting
  • Centre for Trials Research
  • Velindre NHS TrustRecruiting
  • Castle Hill HospitalRecruiting
  • Derby Teaching Hospitals NHS Foundation TrustRecruiting
  • Western General HospitalRecruiting
  • Royal Devon University Health Care NHS Foundation TrustRecruiting
  • Royal Surrey County HospitalRecruiting
  • St James University HospitalRecruiting
  • Liverpool Head and Neck CentreRecruiting
  • University of Liverpool
  • Cwm Taf Bro MorganwgRecruiting
  • University College London Hospitals NHS Foundation TrustRecruiting
  • Guys and St Thomas's NHS Foundation TrustRecruiting
  • St Georges University HospitalRecruiting
  • Imperial College Healthcare NHS TrustRecruiting
  • Central Manchester University Hospital NHS Foundation TrustRecruiting
  • The Christie NHS Foundation TrustRecruiting
  • The Pennine Acute Hospital TrustRecruiting
  • The James Cook University HospitalRecruiting
  • Royal Victoria Infirmary
  • Newcastle upon Tyne Hospitals NHS Foundation TrustRecruiting
  • Aneurin Bevan University Health BoardRecruiting
  • Nottingham City HospitalRecruiting
  • Oxford University Hospitals NHS Foundation TrustRecruiting
  • University Hospital PlymouthRecruiting
  • Queen Alexandra HospitalRecruiting
  • Royal Preston HospitalRecruiting
  • Royal Berkshire HospitalRecruiting
  • University Hospital SouthamptonRecruiting
  • City Hospitals Sunderland NHS Foundation TrustRecruiting
  • Swansea Bay University Local Health BoardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

A: No adjuvant treatment

B1: Postoperative radiotherapy 60 Gray

B2: Postoperative radiotherapy 50 Gray

C1: Postoperative radiotherapy 60 Gray with Cisplatin

C2: Postoperative radiotherapy 60 Gray without chemotherapy

Arm Description

Group A Patients with tumours which exhibit no adverse histological features. Patients in this group will not receive any adjuvant treatment as per standard of care.

Arm B1: postoperative radiotherapy (PORT) at a dose of 60 Gray (Gy) in 30 fractions over 6 weeks. Group B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour.

Arm B2: Postoperative radiotherapy (PORT) at a dose 50 Gray in 25 fractions over 5 weeks. Group B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour.

Arm C1: postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks with concurrent Cisplatin chemotherapy (POCRT). Cisplatin may be given 3 weekly (100mg/m2 week 1 and week 4 of radiotherapy) or weekly (40mg/m2 weekly during radiotherapy), according to local practice. Group C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease

Arm C2: Postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks without chemotherapy (Test Arm C2). Group C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease

Outcomes

Primary Outcome Measures

MDADI/Overall survival co-primary endpoint

Secondary Outcome Measures

Swallowing panel including qualitative and quantitative swallowing assessments
Water swallow test
QOL (using validated EORTC QLQ C30 and HN35 questionnaires)
Quality of Life (QOL) questions.
Acute and late toxicity using CTACE version 4.03
Toxicity assessment
Disease Free Survival
Determined by clinical follow up as per standard guidelines
Locoregional control
Determined by clinical follow up as per standard guidelines
Distant Metastases
Determined by clinical follow up as per standard guidelines

Full Information

First Posted
August 11, 2014
Last Updated
July 19, 2023
Sponsor
Lisette Nixon
Collaborators
UNICANCER, AdventHealth, University of Leipzig, Princess Alexandra Hospital, Brisbane, Australia, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02215265
Brief Title
Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)
Acronym
PATHOS
Official Title
A Phase III Trial of Risk-stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisette Nixon
Collaborators
UNICANCER, AdventHealth, University of Leipzig, Princess Alexandra Hospital, Brisbane, Australia, Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objectives of the PATHOS study are: To assess whether swallowing function can be improved following transoral resection of HPV-positive OPSCC, by reducing the intensity of adjuvant treatment protocols. The aim is to personalise treatment, based on disease biology (HPV status and pathology findings), to optimise patient outcomes. To demonstrate the non-inferiority of reducing the intensity of adjuvant treatment protocols in terms of overall survival in the reduced intensity treatment arms.
Detailed Description
PATHOS is a multicentre, open-label, parallel-group Phase II/III randomised controlled trial (RCT). The phase II target of 242 patients was reached in December 2018 and there was a seamless transition into Phase III. The protocol was amended in September 2018 to incorporate the changes associated with the phase III transition. The amendment included changes to the outcome measures and sample size calculations. Approximately 1100 patients will be recruited to the phase III study. Patients eligible for the study must have biopsy proven oropharyngeal squamous cell carcinoma (OPSCC) clinically staged T1T3 N0N2b. Their primary tumour, as judged by the local MDT, must be considered resectable via a transoral approach. Having secured informed consent, patients with centrally or locally determined HPV positive tumours will undergo baseline assessment of swallowing function (includes; MDADI score, videofluoroscopy, PSSH& N, 100 mL water swallow test) and complete QOL questions (EORTC QLQC30 and EORTC QLQH&N35) prior to surgery. Transoral Laser Microsurgery, Transoral Robotic Surgery & Endoscopically assisted Transoral Surgery are all accepted transoral techniques for the study. A lateral oropharyngectomy performed with monopolar cautery (The Huet Procedure) can also be used. Following surgery and histopathological assessment of the primary tumour and neck dissection surgical specimens, participants will be allocated into study groups based on the presence or absence of pathological risk factors for recurrence as follows: Group A: Participants with tumours which exhibit no adverse histological features. Participants in this group will not receive any adjuvant treatment as per standard of care. Group B: Participants with T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour. Patients in this group will be randomised to PORT 60Gy in 30# over 6 weeks (Control Arm B1) or PORT 50Gy in 25# over 5 weeks (Test Arm B2). Group C: Participants with tumours of any T or any N stage, which exhibit the following high-risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease. Participants in this group will be randomised to POCRT 60Gy in 30# over 6 weeks with concurrent Cisplatin (Control Arm C1) or PORT 60Gy in 30# over 6 weeks without chemotherapy (Test Arm C2). Participants in groups B and C will be stratified before randomisation by T stage, N stage, smoking history and treating centre. The same assessments as at baseline will be completed post-operatively prior to treatment and then at four weeks and 6, 12 and 24 months post-treatment. The exception is videofluoroscopy which will be repeated at post-surgery and 12 months only. Videofluroscopies are only performed at UK sites. Acute and late toxicity will be recorded weekly during treatment and again at 4 weeks and 6, 12 and 24 months post-treatment. All study assessments, complications relating to surgery and adjuvant treatment, in particular complications which necessitate a delay to the start of adjuvant treatment, will all be recorded on the Case Report Form (CRF). International sites have been initiated on Electronic Data Capture (EDC) and local UK sites have transitioned to EDC for participants enrolled after implementation. Data entry needs to be completed within four weeks of the study visit. In accordance with the principles of GCP, the PI is responsible for ensuring accuracy, completeness, legibility and timeliness of the data reported to the CTR in the CRFs. The CRF will be checked for missing, illegible or unusual values (range checks) and consistency over time. If missing or questionable data are identified, a data query will be raised on a data clarification form and sent to the site for resolution. All answered data queries and corrections should be signed off and dated by a delegated member of staff at the relevant participating site. The CTR will send reminders for any overdue data. It is the site's responsibility to submit complete and accurate data in a timely manner. Quality assurance: The clinical trial risk assessment has been used to determine the intensity and focus of central and on-site monitoring activity in the PATHOS trial. Monitoring levels will be employed and are fully documented in the trial monitoring plan. Investigators should agree to allow trial-related monitoring, including audits and regulatory inspections, by providing direct access to source data/documents as required. Patient consent for this will be obtained. Registration: All sites have transitioned to an electronic database and the registration and randomisation process is completed online. Participants will be randomised using minimisation with a random element. This will ensure balanced treatment allocation by clinically important stratification factors. Randomisation will have an allocation ratio of 1:1. Statistical analyses: Primary outcome measure MDADI/Overall survival co-primary endpoint Secondary outcome measures Swallowing panel including qualitative and quantitative swallowing assessments (100ml Water Swallow Test, Videofluoroscopy, Performance Status Scale-Head & Neck) QOL (using validated EORTC QLQ C30 and HN35 questionnaires, Appendix 6) Acute and late toxicity using CTACE version 4.03 Disease-Free Survival* Locoregional control* Distant Metastases* *Determined by clinical follow-up as per standard guidelines (no trial-specific imaging required) The co-primary endpoint of the Phase III will be MDADI and overall survival (time to event). We will use linear regression to estimate the treatment arm effect on MDADI at 12 months and will include the randomisation stratification variables and baseline MDADI in the model. Both OS and MDADI endpoints will be used to define study success so no adjustment for multiplicity is planned. A detailed statistical analysis plan will be developed before the analyses are conducted. The data will be reviewed (approximately six-monthly) by an Independent Data Monitoring Committee (IDMC), consisting of at least two Clinicians (not entering patients into the trial) and an independent Statistician. The IDMC will be asked to recommend whether the accumulated data from the trial, together with results from other relevant trials, justifies continuing recruitment of further patients. A decision to discontinue recruitment, in all patients or selected subgroups, will be made only if the result is likely to convince a broad range of Clinicians including PIs in the trial and the general clinical community. If a decision is made to continue, the IDMC will advise on the frequency of future reviews of the data based on accrual and event rates. Sub-group statistical analyses: For swallowing endpoints, subgroup analysis by T stage and tumour subsite (tonsil, soft palate, tongue base) and surgery technique will be carried out, as the most likely relevant clinical co-variables affecting swallowing function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer
Keywords
Human papillomavirus HPV positive oropharyngeal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: No adjuvant treatment
Arm Type
No Intervention
Arm Description
Group A Patients with tumours which exhibit no adverse histological features. Patients in this group will not receive any adjuvant treatment as per standard of care.
Arm Title
B1: Postoperative radiotherapy 60 Gray
Arm Type
Active Comparator
Arm Description
Arm B1: postoperative radiotherapy (PORT) at a dose of 60 Gray (Gy) in 30 fractions over 6 weeks. Group B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour.
Arm Title
B2: Postoperative radiotherapy 50 Gray
Arm Type
Experimental
Arm Description
Arm B2: Postoperative radiotherapy (PORT) at a dose 50 Gray in 25 fractions over 5 weeks. Group B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour.
Arm Title
C1: Postoperative radiotherapy 60 Gray with Cisplatin
Arm Type
Active Comparator
Arm Description
Arm C1: postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks with concurrent Cisplatin chemotherapy (POCRT). Cisplatin may be given 3 weekly (100mg/m2 week 1 and week 4 of radiotherapy) or weekly (40mg/m2 weekly during radiotherapy), according to local practice. Group C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease
Arm Title
C2: Postoperative radiotherapy 60 Gray without chemotherapy
Arm Type
Experimental
Arm Description
Arm C2: Postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks without chemotherapy (Test Arm C2). Group C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Postoperative radiotherapy
Intervention Description
Postoperative radiotherapy (PORT)
Primary Outcome Measure Information:
Title
MDADI/Overall survival co-primary endpoint
Time Frame
At 12 months following treatment measured using the MD Anderson Dysphagia Inventory (MDADI) score.
Secondary Outcome Measure Information:
Title
Swallowing panel including qualitative and quantitative swallowing assessments
Description
Water swallow test
Time Frame
Baseline; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks) post treatment; 6 months (+/- 4 weeks) post treatment; 12 months (+/- 4 weeks) post treatment; 24 months (+/- 8 weeks) post treatment.
Title
QOL (using validated EORTC QLQ C30 and HN35 questionnaires)
Description
Quality of Life (QOL) questions.
Time Frame
Baseline; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks) post treatment; 6 months (+/- 4 weeks) post treatment; 12 months (+/- 4 weeks) post treatment; 24 months (+/- 8 weeks) post treatment.
Title
Acute and late toxicity using CTACE version 4.03
Description
Toxicity assessment
Time Frame
Weekly during RT and at end of treatment; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks), 6 months (+/- 4 weeks), 12 months (+/- 4 weeks), and 24 months (+/- 8 weeks) post treatment.
Title
Disease Free Survival
Description
Determined by clinical follow up as per standard guidelines
Time Frame
6 months intervals
Title
Locoregional control
Description
Determined by clinical follow up as per standard guidelines
Time Frame
6 months intervals
Title
Distant Metastases
Description
Determined by clinical follow up as per standard guidelines
Time Frame
6 months intervals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed or suspected squamous cell carcinoma of the oropharynx. UICC/AJCC TNM 7th edition stage T1-T3, N0-N2b (or UICC TNM 8th edition stage T1-T3, N0-N1) disease. Multidisciplinary team (MDT) decision to treat with primary transoral resection and neck dissection. Patients considered fit for surgery and adjuvant radiotherapy Aged 18 or over. Written informed consent provided. Exclusion Criteria: Known HPV negative squamous cell carcinomas of the head and neck: A negative result for p16 Immunohistochemistry automatically excludes a patient from the trial. If initial p16 testing is positive but High Risk HPV (HR HPV) In-Situ Hybridization (ISH)/Polymerase Chain Reaction (PCR) does not demonstrate the presence of HR HPV DNA, the patient will also be excluded. Patients who are p16+ may complete swallowing assessments, excluding videofluoroscopy, and surgery whilst HR HPV DNA status is being determined (with recourse to central concordance testing, if appropriate, for UK centres). HPV positivity, as determined by p16 and the demonstration of HR HPV DNA is essential before patients undergo videofluoroscopy or randomisation. T4 and/or T1-T3 tumours where transoral surgery is considered not feasible. UICC/AJCC TNM 7th edition N2c-N3 nodal disease (or UICC/AJCC TNM 8th edition N2-N3 nodal disease). Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality. Current smokers with clinically staged N2b disease (including smokers up to 6 months before diagnosis), even if HPV-positive. Vaping is permitted and should be considered as non-smoking status. Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer. Patients with distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g., CT thorax and upper abdomen or PET-CT. Patients with a history of malignancy in the last 5 years, except basal cell carcinoma of the skin or carcinoma in-situ of the cervix. Women who are pregnant or breastfeeding and fertile women who will not be using contraception during the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mererid Evans, MBBch, PhD
Organizational Affiliation
Velindre NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terrence Jones, MBBS,MD
Organizational Affiliation
Aintree University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Board of Trustees of the Leland Stanford Junior University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Chen
Phone
650-723-5957
Email
nbedi@stanford.edu
Facility Name
Advent Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Haughey
Phone
407-303-0409
Email
bruce.haughey.md@flhosp.org
First Name & Middle Initial & Last Name & Degree
Sara Guyler
Phone
407-543-4000
Ext
1203655
Email
Sara.Guyler@AdventHealth.com
Facility Name
MD Anderson Cancer Centre
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Metro South Health
City
Brisbane
ZIP/Postal Code
QLD 4113
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Panizza, Prof
Email
ben@panizza.com.au
Facility Name
Unicancer
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitham Mirghani (National Coordinator)
Email
haitham.mirghani@aphp.fr
First Name & Middle Initial & Last Name & Degree
Pierre Blanchard
First Name & Middle Initial & Last Name & Degree
Vincent Gregoire
First Name & Middle Initial & Last Name & Degree
Franchel-Rais Obongo-Anga
First Name & Middle Initial & Last Name & Degree
Ovidiu Veresezan
First Name & Middle Initial & Last Name & Degree
Wassila Boukhelif
First Name & Middle Initial & Last Name & Degree
Alexandre Villeneuve
First Name & Middle Initial & Last Name & Degree
Florence Huguet
First Name & Middle Initial & Last Name & Degree
Sylvain Moriniere
First Name & Middle Initial & Last Name & Degree
Guillaume Chambon
First Name & Middle Initial & Last Name & Degree
Philippe Ceruse
Facility Name
Vivantes Klinikum
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Schilling
Email
volker.schilling@vivantes.de
Facility Name
Asklepios Kliniken
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silke Tribius
Email
silke@tribius.de
Facility Name
Universitat Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Wiegand
Email
Susanne.Wiegand@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Silke Tribius
Facility Name
Ernst von Bergmann Klinikum
City
Potsdam
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Jungehulsing
Phone
0331/241-36007
Email
mjungehuelsing@klinikumevb.de
Facility Name
Städtisches Klinikum Solingen
City
Solingen
ZIP/Postal Code
42653
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A.M Sesterhenn
Phone
00492125472738
Email
sesterhenn@klinikumsolingen.de
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Laban
Phone
0731 500 59543
Email
Simon.laban@uniklinik-ulm.de
Facility Name
University Hospitals Dorset NHS Foundation
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma King, Dr
Email
emmabarker@doctors.org.uk
Facility Name
Royal United Hospitals Bath NHS Foundation Trust
City
Bath
ZIP/Postal Code
BA1 3NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma De Winton, Dr
Email
emma.dewinton@nhs.net
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Hartley, Dr
Email
andrew.hartley@uhb.nhs.uk
Facility Name
Royal Blackburn Hospital
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panayiotis Kyzas, Mr
Email
Panayiotis.Kyzas@elht.nhs.uk
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy Bradley
Phone
01273 696955
Ext
63911
Email
katy.bradley2@nhs.net
First Name & Middle Initial & Last Name & Degree
Katy Bradley
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Beasley, Dr
Email
Matthew.Beasley@UHBristol.nhs.uk
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irune Ekpemi, Miss
Email
ekpemi.irune@addenbrookes.nhs.uk
Facility Name
Kent and Canterbury Hospital
City
Canterbury
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Hone
Email
rhone@nhs.net
Facility Name
HPV Research Group Section of Pathology Cardiff University ,School of Medicine
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ned Powell, Dr
Email
PowellNG@cardiff.ac.uk
Facility Name
Cardiff and Vale University Local Health Board
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeep Berry, Mr
Email
Sandeep.Berry@wales.nhs.uk
Facility Name
Centre for Trials Research
City
Cardiff
ZIP/Postal Code
CF14 4YS
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Hurt
Phone
02920687471
Email
HurtCN@cardiff.ac.uk
Facility Name
Velindre NHS Trust
City
Cardiff
ZIP/Postal Code
CF142TL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mererid Evans, Professor
Email
Mererid.Evans@wales.nhs.uk
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorcan O'Toole, Dr
Email
lorcan.otoole@hey.nhs.uk
Facility Name
Derby Teaching Hospitals NHS Foundation Trust
City
Derby
ZIP/Postal Code
DE22 3DT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Mortimore, Mr
Email
sean.mortimore@nhs.net
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iain Nixon, Mr
Email
iain.nixon@nhs.net
Facility Name
Royal Devon University Health Care NHS Foundation Trust
City
Exeter
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Smith
Email
joel.smith2@nhs.net
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Derbyshire, Mr
Email
stephen.derbyshire2@nhs.net
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Cardale, Dr
Email
kate.cardale@nhs.net
Facility Name
Liverpool Head and Neck Centre
City
Liverpool
ZIP/Postal Code
L3 9TA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Jones, Professor
Email
T.M.Jones@liverpool.ac.uk
Facility Name
University of Liverpool
City
Liverpool
ZIP/Postal Code
L69 3GB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Patterson, Prof
Email
Joanne.Patterson@liverpool.ac.uk
Facility Name
Cwm Taf Bro Morganwg
City
Llantrisant
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Webster, Dr
Email
Richard.Webster@wales.nhs.uk
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Hughes, Mr
Email
jonathan.hughes1@nhs.net
Facility Name
Guys and St Thomas's NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asit Arora, Mr
Email
Asit.Arora@gstt.nhs.uk
Facility Name
St Georges University Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enyinnaya Ofo
Phone
0208 725 2052
Email
enyinnaya.ofo@stgeorges.nhs.uk
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
SW7 2AZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaid Awad, Mr
Email
zawad@nhs.net
Facility Name
Central Manchester University Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarrod Homer, Professor
Email
jarrod.j.homer@manchester.ac.uk
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Thomson, Dr
Email
david.thomson@christie.nhs.uk
Facility Name
The Pennine Acute Hospital Trust
City
Manchester
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kapil Java, Mr
Email
kapil.java@mft.nhs.uk
Facility Name
The James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shane Lester, Mr
Email
shanelester@nhs.net
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Robinson, Dr
Email
max.robinson@nhs.net
Facility Name
Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James O'Hara, Mr
Email
James.Ohara@nuth.nhs.uk
Facility Name
Aneurin Bevan University Health Board
City
Newport
ZIP/Postal Code
NP18 3XQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Passant, Mr
Email
Carl.Passant@wales.nhs.uk
Facility Name
Nottingham City Hospital
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeraj Sethi
Email
Neeraj.Sethi@nuh.nhs.uk
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Winter, Mr
Email
stuart.winter@ouh.nhs.uk
Facility Name
University Hospital Plymouth
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Williams, Mr
Email
richard.williams8@nhs.net
Facility Name
Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Costa Repanos, Mr
Email
costa.repanos@porthosp.nhs.uk
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharan Jayaram
Phone
01772522074
Email
Sharan.ChakkyathJayaram@LTHTR.nhs.uk
Facility Name
Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Dallas, Dr
Email
Nicola.Dallas@royalberkshire.nhs.uk
Facility Name
University Hospital Southampton
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satish Harinarayanan, Dr
Email
sathish.harinarayanan@uhs.nhs.uk
Facility Name
City Hospitals Sunderland NHS Foundation Trust
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Cocks, Dr
Email
helen.cocks@chsft.nhs.uk
Facility Name
Swansea Bay University Local Health Board
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conor Marnane, Mr
Email
conor.marnane@wales.nhs.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
26311526
Citation
Owadally W, Hurt C, Timmins H, Parsons E, Townsend S, Patterson J, Hutcheson K, Powell N, Beasley M, Palaniappan N, Robinson M, Jones TM, Evans M. PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer. BMC Cancer. 2015 Aug 27;15:602. doi: 10.1186/s12885-015-1598-x.
Results Reference
derived

Learn more about this trial

Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)

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