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PET/CT Scan-Guided Watchful Waiting or Neck Dissection of Locally Advanced Lymph Node Metastases in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Primary Head And Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
positron emission tomography/computed tomography
therapeutic conventional surgery
Sponsored by
Warwick Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I verrucous carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III verrucous carcinoma of the oral cavity, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, tongue cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed head and neck squamous cell carcinoma (HNSCC), including any of the following subtypes:

    • Oropharyngeal
    • Laryngeal
    • Oral
    • Hypopharyngeal
  • No primary nasopharyngeal carcinoma

  • Must have clinical and CT/MRI evidence of nodal metastases staged N2 (a, b, or c) or N3

    • No occult nodal metastasis (i.e., large nodal metastasis but no proven primary site on clinical assessment)
    • No N1 nodal metastasis

  • Planning to receive curative radical concurrent chemoradiotherapy (approved by study) for primary disease

    • Patients undergoing neoadjuvant chemotherapy followed by concurrent chemoradiotherapy are eligible
  • Able to undergo neck dissection surgery
  • No current resection for primary tumor planned (e.g., resection of tonsil or base of tongue with flap reconstruction [diagnostic tonsillectomy allowed])
  • No distant metastases to chest, liver, bones, or other sites

PATIENT CHARACTERISTICS:

  • Not pregnant
  • No other cancer diagnosis within the past 5 years except basal cell carcinoma or cervical carcinoma in situ

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior treatment for HNSCC
  • No concurrent neoadjuvant chemoradiotherapy without concurrent chemotherapy
  • No concurrent adjuvant chemotherapy
  • No concurrent chemoradiotherapy for palliative purposes
  • No concurrent radiotherapy alone

Sites / Locations

  • Warwick Medical School Clinical Trials UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of primary site undergo neck dissection within 4 weeks.

Patients undergo neck dissection and receive standard concurrent CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.

Outcomes

Primary Outcome Measures

Overall survival at 2 years
Health economics using quality adjusted life years

Secondary Outcome Measures

Disease-specific survival
Recurrence and local control in neck
Utility cost
Quality of life
Complication rates
Accuracy of PET-CT scanning for assessing primary tumor

Full Information

First Posted
July 19, 2008
Last Updated
August 23, 2013
Sponsor
Warwick Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00720070
Brief Title
PET/CT Scan-Guided Watchful Waiting or Neck Dissection of Locally Advanced Lymph Node Metastases in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Primary Head And Neck Cancer
Official Title
A Multi-centre Randomised Phase III Trial Comparing PET-CT Guided Watch and Wait Policy Versus Planned Neck Dissection for the Management of Locally Advanced (N2/N3) Nodal Metastases in Patients With Head and Neck Squamous Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Warwick Medical School

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Imaging procedures, such as PET/CT scan, produce pictures of areas inside the body and may help doctors detect residual disease and plan the best treatment. Neck dissection is surgery to remove lymph nodes and other tissues in the neck. It is not yet known whether a neck dissection should always be performed in treating patients with head and neck cancer. PURPOSE: This randomized phase III trial is studying PET/CT scan-guided watchful waiting compared with neck dissection of locally advanced lymph node metastases in treating patients who are undergoing chemotherapy and radiation therapy for primary head and neck cancer.
Detailed Description
OBJECTIVES: To compare the efficacy, in terms of overall survival, disease-specific survival, recurrence, quality of life, and cost-effectiveness, of a PET/CT scan-guided watch and wait policy with the current practice of planned neck dissection in the management of advanced (N2 or N3) nodal metastases in patients with primary head and neck squamous cell carcinoma undergoing chemoradiotherapy. To assess the predictive value of PET/CT scanning in detecting persistent or residual disease in the primary site. OUTLINE: This is a multicenter study. Patients are stratified according to center, chemotherapy schedule (concurrent platinum vs concurrent cetuximab vs neoadjuvant and concurrent platinum vs neoadjuvant docetaxel, platinum, and fluorouracil with concurrent platinum), T stage (T1-T2 vs T3-T4), and N stage (N2a-N2b vs N2c-N3). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of primary site undergo neck dissection within 4 weeks. Arm II: Patients undergo neck dissection and then receive standard CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients are assessed periodically for quality-of-life. Tissue and blood samples collected periodically are stored for future research. After completion of study treatment, patients are followed monthly for 1 year and then bimonthly for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I verrucous carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III verrucous carcinoma of the oral cavity, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, tongue cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of primary site undergo neck dissection within 4 weeks.
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
Patients undergo neck dissection and receive standard concurrent CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography/computed tomography
Intervention Description
Patients undergo PET/CT scan
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Patients undergo neck dissection
Primary Outcome Measure Information:
Title
Overall survival at 2 years
Title
Health economics using quality adjusted life years
Secondary Outcome Measure Information:
Title
Disease-specific survival
Title
Recurrence and local control in neck
Title
Utility cost
Title
Quality of life
Title
Complication rates
Title
Accuracy of PET-CT scanning for assessing primary tumor

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed head and neck squamous cell carcinoma (HNSCC), including any of the following subtypes: Oropharyngeal Laryngeal Oral Hypopharyngeal No primary nasopharyngeal carcinoma Must have clinical and CT/MRI evidence of nodal metastases staged N2 (a, b, or c) or N3 No occult nodal metastasis (i.e., large nodal metastasis but no proven primary site on clinical assessment) No N1 nodal metastasis Planning to receive curative radical concurrent chemoradiotherapy (approved by study) for primary disease Patients undergoing neoadjuvant chemotherapy followed by concurrent chemoradiotherapy are eligible Able to undergo neck dissection surgery No current resection for primary tumor planned (e.g., resection of tonsil or base of tongue with flap reconstruction [diagnostic tonsillectomy allowed]) No distant metastases to chest, liver, bones, or other sites PATIENT CHARACTERISTICS: Not pregnant No other cancer diagnosis within the past 5 years except basal cell carcinoma or cervical carcinoma in situ PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior treatment for HNSCC No concurrent neoadjuvant chemoradiotherapy without concurrent chemotherapy No concurrent adjuvant chemotherapy No concurrent chemoradiotherapy for palliative purposes No concurrent radiotherapy alone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham Mehanna, MD
Organizational Affiliation
Warwick Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warwick Medical School Clinical Trials Unit
City
Coventry
State/Province
England
ZIP/Postal Code
CV4 7AL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hisham Mehanna, MD
Phone
44-247-696-5606

12. IPD Sharing Statement

Learn more about this trial

PET/CT Scan-Guided Watchful Waiting or Neck Dissection of Locally Advanced Lymph Node Metastases in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Primary Head And Neck Cancer

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