Know Cancer

or
forgot password

PHASE III TRIAL TO PRESERVE THE LARYNX: INDUCTION CHEMOTHERAPY AND RADIATION THERAPY VERSUS CONCOMITANT CHEMOTHERAPY AND RADIATION THERAPY VERSUS RADIATION THERAPY


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

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 InstituteTampa, Florida  33612
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Ireland Cancer CenterCleveland, 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 AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213