PHASE III TRIAL TO PRESERVE THE LARYNX: INDUCTION CHEMOTHERAPY AND RADIATION THERAPY VERSUS CONCOMITANT CHEMOTHERAPY AND RADIATION THERAPY VERSUS RADIATION THERAPY
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
PHASE III TRIAL TO PRESERVE THE LARYNX: INDUCTION CHEMOTHERAPY AND RADIATION THERAPY VERSUS CONCOMITANT CHEMOTHERAPY AND RADIATION THERAPY VERSUS RADIATION THERAPY
OBJECTIVES: I. Compare, in a phase III setting, overall and disease-free survival with
preservation of laryngeal function in patients with stage III/IV squamous cell carcinoma of
the glottic and supraglottic larynx treated with cisplatin/fluorouracil (CDDP/5-FU) followed
by radiotherapy vs. concomitant radiotherapy plus CDDP vs. radiotherapy alone. II. Compare
the tumor response after completion of chemotherapy but prior to initiation of radiotherapy
with that following completion of radiotherapy and concurrent chemotherapy. III. Compare the
patterns of relapse (local and regional recurrence and distant metastasis) with these
treatments. IV. Compare the incidence of second primary tumors in patients treated on these
three regimens. V. Compare the acute and chronic adverse effects of these three regimens.
VI. Compare the morbidity experienced with neck dissection and/or laryngeal salvage surgery
following treatment with these regimens. VII. Compare quality of life of patients with
laryngeal preservation vs. patients requiring salvage laryngectomies. VIII. Compare the
quality of life of patients receiving radiotherapy alone vs. those receiving chemotherapy as
well.
OUTLINE: Randomized study. Patients on any arm, clinically staged N+ undergo neck dissection
following completion of radiotherapy. Arm I: 2-Drug Combination Chemotherapy followed by
Radiotherapy. Cisplatin, CDDP, NSC-119875; Fluorouracil, 5-FU, NSC-19893; followed by
regional irradiation using linear accelerators with photon energies of 1.25-6 MV, electron
energies of 8-17 MeV, or Co60. Arm II: Radiotherapy plus Single-Agent
Chemotherapy/Radiosensitization. Regional irradiation using equipment as in Arm I; plus
CDDP. Arm III: Radiotherapy. Regional irradiation using equipment as in Arm I.
PROJECTED ACCRUAL: 546 patients (182/arm) will be entered over approximately 3 years. If any
arm is clearly inferior in laryngectomy-free survival after 137 patients have completed 2
years of follow-up study, that arm will be closed to further accrual. A second interim
analysis will be conducted after 410 patients have completed 2 years of follow-up.
Inclusion Criteria
DISEASE CHARACTERISTICS: Biopsy-proven, previously untreated, squamous cell carcinoma of
the glottic and supraglottic larynx that would normally require total laryngectomy Stage
III/IV disease (excluding T1 and M1) Endoscopic tumor staging required within 4 weeks of
entry Tumors must be considered resectable and potentially curable with conventional
surgery and radiotherapy T4 disease limited to: Up to 1 cm invasion of the base of tongue
Questionable cartilage invasion on CT (clinically T3) Measurable disease required No
synchronous primary tumors No subglottic tumors
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%
Hematopoietic: (obtained within 3 weeks of entry) WBC at least 3,500 Platelets at least
100,000 Hepatic: Not specified Renal: (obtained within 2 weeks of entry) Creatinine
clearance at least 50 mL/min (measured or calculated) Serum calcium normal Cardiovascular:
Status adequate to tolerate all protocol therapy Pulmonary: Status adequate to tolerate
all protocol therapy Other: Nutritional status adequate to tolerate all protocol therapy
Mental status adequate to follow instructions and keep appointments No second malignancy
except nonmelanomatous skin cancer (Patients who have been disease-free for at least 3
years following treatment for a prior cancer may be eligible at the discretion of the
protocol chairman) Negative pregnancy test required of fertile women Effective
contraception required of fertile women
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior
therapy Endocrine therapy: No prior therapy Radiotherapy: No prior radiotherapy to the
head and neck Surgery: No prior therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Helmuth Goepfert, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000077756
NCT ID:
NCT00002496
Start Date:
August 1992
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- Laryngeal Neoplasms
- Head and Neck Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| New England Medical Center Hospital | Boston, Massachusetts 02111 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
