Head and Neck Cancer Clinical Trial
Official title:
PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to
preserve the part of the body where the cancer started. It is not yet known which regimen of
cisplatin and fluorouracil combined with radiation therapy is more effective in treating
resectable cancer of the hypopharynx or larynx.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin
and fluorouracil combined with radiation therapy in preserving the larynx in patients who
have resectable cancer of the hypopharynx or larynx.
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.
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