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Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
amifostine trihydrate
cisplatin
fluorouracil
surgical procedure
radiation therapy
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III lip and oral cavity cancer, stage IV lip and oral cavity cancer, recurrent lip and oral cavity cancer, stage III hypopharyngeal cancer, stage IV hypopharyngeal cancer, recurrent hypopharyngeal cancer, stage III laryngeal cancer, stage IV laryngeal cancer, recurrent laryngeal cancer, stage III paranasal sinus and nasal cavity cancer, stage IV paranasal sinus and nasal cavity cancer, recurrent paranasal sinus and nasal cavity cancer, stage III oropharyngeal cancer, stage IV oropharyngeal cancer, recurrent oropharyngeal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or new primary squamous cell carcinoma of the head and neck occurring in a previously irradiated field Pathologic stage of recurrence must be rT3-4 and/or rN2-3 The following sites are eligible: Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+ Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+ Any site: Positive margin(s), at least 2 nodes or ECS No primary tumor of the nasopharynx Must be eligible for or have undergone complete resection which leaves behind no gross residual disease Must have prior head and neck irradiation of 45-75 Gy Lifetime spinal cord radiotherapy dose no greater than 50 Gy No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery) No active acute radiation mucositis from previous radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Hemoglobin at least 9 g/dL (transfusion allowed) Platelet count at least 100,000/mm^3 Hepatic: SGOT or SGPT no greater than 3 times upper limit of normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled arrhythmias within past 6 months No severe cerebrovascular disease or hypotension not caused by antihypertensive medication Other: Not pregnant Fertile patients must use effective contraception No allergy to cisplatin, fluorouracil, or amifostine No uncontrolled insulin-dependent diabetes mellitus or other medical condition interfering with wound healing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy) Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 6 months since prior radiotherapy Prior radiotherapy treatment records must be available Surgery: No prior salvage surgery consisting of partial laryngectomy

Sites / Locations

  • University of Pennsylvania Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 11, 2022
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00003777
Brief Title
Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
Official Title
A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
December 1998 (Actual)
Primary Completion Date
April 2001 (Actual)
Study Completion Date
April 20, 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

5. Study Description

Brief Summary
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. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.
Detailed Description
OBJECTIVES: Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer. Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients. OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32. Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage III lip and oral cavity cancer, stage IV lip and oral cavity cancer, recurrent lip and oral cavity cancer, stage III hypopharyngeal cancer, stage IV hypopharyngeal cancer, recurrent hypopharyngeal cancer, stage III laryngeal cancer, stage IV laryngeal cancer, recurrent laryngeal cancer, stage III paranasal sinus and nasal cavity cancer, stage IV paranasal sinus and nasal cavity cancer, recurrent paranasal sinus and nasal cavity cancer, stage III oropharyngeal cancer, stage IV oropharyngeal cancer, recurrent oropharyngeal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
amifostine trihydrate
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Procedure
Intervention Name(s)
surgical procedure
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or new primary squamous cell carcinoma of the head and neck occurring in a previously irradiated field Pathologic stage of recurrence must be rT3-4 and/or rN2-3 The following sites are eligible: Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+ Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+ Any site: Positive margin(s), at least 2 nodes or ECS No primary tumor of the nasopharynx Must be eligible for or have undergone complete resection which leaves behind no gross residual disease Must have prior head and neck irradiation of 45-75 Gy Lifetime spinal cord radiotherapy dose no greater than 50 Gy No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery) No active acute radiation mucositis from previous radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Hemoglobin at least 9 g/dL (transfusion allowed) Platelet count at least 100,000/mm^3 Hepatic: SGOT or SGPT no greater than 3 times upper limit of normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled arrhythmias within past 6 months No severe cerebrovascular disease or hypotension not caused by antihypertensive medication Other: Not pregnant Fertile patients must use effective contraception No allergy to cisplatin, fluorouracil, or amifostine No uncontrolled insulin-dependent diabetes mellitus or other medical condition interfering with wound healing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy) Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 6 months since prior radiotherapy Prior radiotherapy treatment records must be available Surgery: No prior salvage surgery consisting of partial laryngectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Machtay, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

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Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer

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