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Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer

Primary Purpose

Carcinoma of Unknown Primary, Head and Neck Cancer

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

mitomycin C

porfiromycin

brachytherapy

radiation therapy

About this trial

This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring stage I squamous cell carcinoma of the lip and oral cavity, stage I adenoid cystic carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II adenoid cystic carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage I squamous cell carcinoma of the oropharynx, stage I lymphoepithelioma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the nasopharynx, stage I lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Biopsy-proven epidermoid carcinoma of the following head and neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasopharynx Unknown primary origin with positive head and neck nodes TNM Stages I-IV or recurrent disease with no distant metastases, i.e.: T1 N0 M0 T1 N1-3 M0 T2-4 any N M0 T0 N1-3 M0 No carcinoma of the true vocal cord or other condition with greater than 90% probability of cure PATIENT CHARACTERISTICS: Age: 20 to 80 Performance status: Not specified Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hct at least 25% Hepatic: Bilirubin less than 1.5 mg/dl Renal: Creatinine less than 2 mg/dl OR BUN less than 40 mg/dl Other: No other serious, life-threatening illness No second malignancy within 5 years except nonmelanomatous skin cancer outside the planned radiotherapy field PRIOR CONCURRENT THERAPY: At least 3 years since chemotherapy No prior radiotherapy to areas of current disease

Sites / Locations

Yale Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002507

First Posted

November 1, 1999

Last Updated

July 24, 2013

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT00002507

Brief Title

Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer

Official Title

RADIATION WITH MITOMYCIN C OR PORFIROMYCIN IN THE TREATMENT OF CANCER OF THE HEAD AND NECK AREA

Study Type

Interventional

2. Study Status

Record Verification Date

June 2000

Overall Recruitment Status

Completed

Study Start Date

November 1992 (undefined)

Primary Completion Date

October 2002 (Actual)

Study Completion Date

October 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combining mitomycin or porfiromycin with radiation therapy is more effective in treating patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus either mitomycin or porfiromycin in treating patients with head and neck cancer.

Detailed Description

OBJECTIVES: I. Compare the efficacy of mitomycin vs. porfiromycin as an adjunct to radiotherapy for the treatment of epidermoid carcinomas of the head and neck. OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Irradiation of involved head and neck sites by external-beam radiotherapy (EBRT) alone (source not specified), brachytherapy alone (using permanent or removable radiation sources), or both; plus Mitomycin, MITO, NSC-26980. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Radiotherapy as in Arm I; plus Porfiromycin, NSC-56410. PROJECTED ACCRUAL: Approximately 200 patients will be entered over 3-4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma of Unknown Primary, Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the lip and oral cavity, stage I adenoid cystic carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II adenoid cystic carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage I squamous cell carcinoma of the oropharynx, stage I lymphoepithelioma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the nasopharynx, stage I lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

mitomycin C

Intervention Type

Drug

Intervention Name(s)

porfiromycin

Intervention Type

Radiation

Intervention Name(s)

brachytherapy

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James J. Fischer, MD, PhD

Organizational Affiliation

Yale University

Official's Role

Study Chair

Facility Information:

Facility Name

Yale Comprehensive Cancer Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520-8028

Country

United States

12. IPD Sharing Statement

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Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer

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