PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS
OBJECTIVES:
- Compare relapse-free survival and larynx preservation in patients with resectable
hypopharyngeal or laryngeal cancer treated with sequential vs alternating cisplatin and
fluorouracil and radiotherapy.
- Compare the health-related quality of life in patients treated with these regimens.
- Compare the cost-effectiveness of these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by performance
status, disease site, tumor stage, node stage, and center.
Patients are randomized to one of two treatment arms. Both groups may receive either
conventional radiotherapy in single daily fractions, 5 days per week, for 7 weeks (option 1)
or hyperfractionated radiotherapy in 2 daily fractions, 5 days per week, for 4-5 weeks
(option 2), according to institutional policy.
- Arm I: Patients receive cisplatin and fluorouracil every 3 weeks. Patients with a
complete or partial response on day 42 receive 2 additional courses of chemotherapy
followed by 7 weeks of radiotherapy beginning on day 80. After radiotherapy, patients
with a complete remission enter follow-up; those with a partial remission proceed to
surgery. Patients with stable or progressive disease proceed immediately to surgery
with or without postoperative radiotherapy.
- Arm II: Patients receive cisplatin and fluorouracil every 3 weeks for 4 courses.
Patients treated on radiotherapy option 1 are evaluated 2 months after completion of
radiotherapy; those with a complete remission enter follow-up while all others proceed
to surgery. Patients treated on option 2 are evaluated on day 42; those with a partial
or complete response complete chemoradiotherapy and are then evaluated and treated like
option 1 patients. Patients with stable or progressive disease on day 42 proceed to
surgery with or without a third course of chemotherapy on week 7.
Patients are followed every 3 months for 3 years and at least every 6 months thereafter.
PROJECTED ACCRUAL: A total of 564 patients will be accrued for this study within 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven squamous cell carcinoma of the head and neck, including:
- Stage III/IV cancer of the glottic or supraglottic larynx
- Eligible T4 tumor defined as:
- Bulging the valleculae
- Bulging the hyothyroid membrane
- Minimal thyroid cartilage invasion or suspicion of invasion on imaging
- Stage II/III/IV cancer of the pyriform sinus or of the hypopharyngeal aspect of
the aryepiglottic fold (with or without extension to postcricoid area)
- No massive destruction of the thyroid cartilage
- No continuity between primary tumor and a lymph node
- Operable on first attempt (as assessed by head and neck surgeon) by classical total
laryngectomy with or without partial pharyngectomy
- No requirement for extended surgery (circumferential pharyngolaryngectomy)
- No tumor suitable for partial (functional) surgery or requiring extended surgery
that necessitates any kind of flap for closure
- No N2c tumor unless no requirement for bilateral resection of internal jugular
veins
- Measurable or evaluable disease by panendoscopy and CT scan or MRI
- Esophagoscopy required
- Bronchofiberscopy recommended
- No requirement for tracheotomy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2 OR
- WHO 0-2
Hematopoietic:
- WBC at least 4,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Other:
- No medical, psychological, or geographical condition that precludes study compliance
- No serious nonmalignant systemic disease
- No second malignancy except:
- Carcinoma in situ of the cervix
- Adequately treated nonmelanomatous skin cancer
- No poor nutritional status unlikely to be restored to fair status within 3 weeks
- No contraindication to CT scan or general anesthesia
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior anticancer biologic therapy
Chemotherapy
- No prior anticancer chemotherapy
Endocrine therapy
- No prior anticancer endocrine therapy
Radiotherapy
- No prior anticancer radiotherapy
Surgery
- See Disease Characteristics
Other
- No other prior anticancer therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Jean-Louis Lefebvre, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Oscar Lambret
Authority:
United States: Federal Government
Study ID:
EORTC-24954
NCT ID:
NCT00002839
Start Date:
July 1996
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage II squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- Head and Neck Neoplasms
- Laryngeal Diseases
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