Status:
UNKNOWN
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
Lead Sponsor:
Warwick Medical School
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 re...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT00720070
Start Date
September 1 2007
Last Update
August 26 2013
Active Locations (1)
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1
Warwick Medical School Clinical Trials Unit
Coventry, England, United Kingdom, CV4 7AL