search
Back to results

TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer (Condor)

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
conventional radiotherapy with 'high' dose cisplatin
accelerated radiotherapy with 'low' dose cisplatin
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring HNSCC, neo Adjuvant, Chemoradiation therapy, TPF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histology and staging disease

  • Histologically or cytologically proven non-metastatic locally advanced HNSCC, stage III or IV, for which concomitant chemo-radiotherapy would be the standard therapy
  • Patients can be included either with irresectable disease or for which the concomitant chemoradiotherapy was chosen for organ preservation
  • Measurable disease
  • Primary site: oral cavity, oropharynx, hypopharynx and larynx

General conditions

  • Written informed consent
  • Age >18 years and ≤ 65 years
  • WHO performance status 0-1
  • Adequate bone marrow function (WBC > 3.0 x 109/L, platelets > 100 x 109/L, Hb > 6 mmol/L)
  • Adequate hepatic function: total bilirubin < 1. 5 x upper normal limit, ASAT and ALAT < 2.5 x upper normal limits
  • Adequate renal function: calculated creatinin clearance > 60ml/min. (Cockcroft-Gault formula) Other
  • Expected adequacy of follow-up.

Exclusion Criteria:

General conditions

  • Active alcohol addiction
  • Admission for COPD in the last 12 months
  • Weight loss > 10% in 3 months before entry
  • Pregnancy or lactation
  • Patients (M/F) with reproductive potential not implementing adequate contraceptives measures

Prior or current history

  • Prior surgery, radiotherapy or chemotherapy for this tumor
  • Serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or likely to interfere with the study assessments
  • Serious active infections
  • Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin

Concomitant treatments

  • Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation
  • Concurrent treatment with any other anti-cancer therapy

Sites / Locations

  • Netherlands Cancer InstituteRecruiting
  • University Medical Center Nijmegen st RadboudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Induction Chemotherapy with TPF Then: cisplatin 100 mg/m2 on day 1, 22 and 43 combined with conventional radiotherapy

Induction chemotherapy with TPF Then cisplatin 40mg/m2 on day 1,8,15,22,29 and 35 combined with accelerated radiotherapy

Outcomes

Primary Outcome Measures

feasibility of both study-arms

Secondary Outcome Measures

to assess the toxicity profile, tumour response, disease free survival and overall survival in both study-arms. Also QoL will be measured.

Full Information

First Posted
October 16, 2008
Last Updated
April 10, 2012
Sponsor
Radboud University Medical Center
Collaborators
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00774319
Brief Title
TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer
Acronym
Condor
Official Title
A Randomised Study of TPF as Neoadjuvant Chemotherapy Followed by Concomitant Chemoradiotherapy (CRT) With Conventional Radiotherapy (RT) Versus Concomitant CRT With Accelerated RT in Patients With Locally Advanced Head and Neck Squamous Cell Cancer (HNSCC) in Good Condition. The Condor Study. A Study of the Dutch Head and Neck Cancer Group (DHNCG).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to compare two different treatments for fit patients with head and neck cancer: All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU). Subsequently patients are being randomised into two groups: The first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and conventional radiotherapy The second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and accelerated radiotherapy.
Detailed Description
Induction Chemotherapy TPF(arm A and B) : Docetaxel 75 mg/m2 iv on day 1, Cisplatin 75 mg/ m2 iv on day 1, 5-FU 750 mg/ m2/day iv continuous infusion (in Hickman or port a cath) on days 1-5; prophylactic G-CSF This cycle will be repeated every 21 days for a maximum of 4 cycles. Clinical evaluation after each cycle and radiological evaluation after 2 cycles will take place. In case of PD or SD (after 2 cycles) with no minor response (no decrease in measurable disease from baseline) concomitant chemoradiotherapy will started per protocol. Surgery The investigators in each centre can decide neck surgery for residual tumor

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
HNSCC, neo Adjuvant, Chemoradiation therapy, TPF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Induction Chemotherapy with TPF Then: cisplatin 100 mg/m2 on day 1, 22 and 43 combined with conventional radiotherapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Induction chemotherapy with TPF Then cisplatin 40mg/m2 on day 1,8,15,22,29 and 35 combined with accelerated radiotherapy
Intervention Type
Radiation
Intervention Name(s)
conventional radiotherapy with 'high' dose cisplatin
Intervention Description
radiotherapy: 5 fractions/week, total treatment time 7 weeks. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions. 100 mg/m2 cisplatin iv on day 1, 22 and 43
Intervention Type
Radiation
Intervention Name(s)
accelerated radiotherapy with 'low' dose cisplatin
Intervention Description
Accelerated radiotherapy 6 fractions/week, total treatment time 6 weeks. During one of the weekdays two fractions will be delivered with an interval of at least 6h. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions cisplatin 40 mg/m2 iv on day 1,8,18,22,29,35
Primary Outcome Measure Information:
Title
feasibility of both study-arms
Time Frame
2 years
Secondary Outcome Measure Information:
Title
to assess the toxicity profile, tumour response, disease free survival and overall survival in both study-arms. Also QoL will be measured.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histology and staging disease Histologically or cytologically proven non-metastatic locally advanced HNSCC, stage III or IV, for which concomitant chemo-radiotherapy would be the standard therapy Patients can be included either with irresectable disease or for which the concomitant chemoradiotherapy was chosen for organ preservation Measurable disease Primary site: oral cavity, oropharynx, hypopharynx and larynx General conditions Written informed consent Age >18 years and ≤ 65 years WHO performance status 0-1 Adequate bone marrow function (WBC > 3.0 x 109/L, platelets > 100 x 109/L, Hb > 6 mmol/L) Adequate hepatic function: total bilirubin < 1. 5 x upper normal limit, ASAT and ALAT < 2.5 x upper normal limits Adequate renal function: calculated creatinin clearance > 60ml/min. (Cockcroft-Gault formula) Other Expected adequacy of follow-up. Exclusion Criteria: General conditions Active alcohol addiction Admission for COPD in the last 12 months Weight loss > 10% in 3 months before entry Pregnancy or lactation Patients (M/F) with reproductive potential not implementing adequate contraceptives measures Prior or current history Prior surgery, radiotherapy or chemotherapy for this tumor Serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or likely to interfere with the study assessments Serious active infections Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin Concomitant treatments Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation Concurrent treatment with any other anti-cancer therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
C.M.L. van Herpen, Md, Phd
Phone
31 24 3610353
Email
c.vanherpen@onco.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.M.L. van Herpen, MD, Phd
Organizational Affiliation
UMCN st Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netherlands Cancer Institute
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.P. de Boer
Phone
31 20 512 9111
Email
j.d.boer@nki.nl
First Name & Middle Initial & Last Name & Degree
J.P. de Boer
Facility Name
University Medical Center Nijmegen st Radboud
City
Nijmegen
ZIP/Postal Code
6525 GH
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C.M.L van Herpen, Md, Phd

12. IPD Sharing Statement

Citations:
PubMed Identifier
29230548
Citation
Driessen CML, Groenewoud JMM, de Boer JP, Gelderblom H, van der Graaf WTA, Prins JB, Kaanders JHAM, van Herpen CML. Quality of life of patients with locally advanced head and neck cancer treated with induction chemotherapy followed by cisplatin-containing chemoradiotherapy in the Dutch CONDOR study: a randomized controlled trial. Support Care Cancer. 2018 Apr;26(4):1233-1242. doi: 10.1007/s00520-017-3946-7. Epub 2017 Dec 11.
Results Reference
derived
PubMed Identifier
26655558
Citation
Driessen CM, de Boer JP, Gelderblom H, Rasch CR, de Jong MA, Verbist BM, Melchers WJ, Tesselaar ME, van der Graaf WT, Kaanders JH, van Herpen CM. Induction chemotherapy with docetaxel/cisplatin/5-fluorouracil followed by randomization to two cisplatin-based concomitant chemoradiotherapy schedules in patients with locally advanced head and neck cancer (CONDOR study) (Dutch Head and Neck Society 08-01): A randomized phase II study. Eur J Cancer. 2016 Jan;52:77-84. doi: 10.1016/j.ejca.2015.09.024. Epub 2015 Dec 1.
Results Reference
derived

Learn more about this trial

TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer

We'll reach out to this number within 24 hrs