A Two Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy (Weekly Cisplatin-Arm1) And Amifostine (Arm 2) In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes
18 Years
N/A
Female
Cervical Cancer, Radiation Toxicity
Trial Information
A Two Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy (Weekly Cisplatin-Arm1) And Amifostine (Arm 2) In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes
OBJECTIVES:
- Determine the feasibility and tolerability of external beam radiotherapy,
brachytherapy, and cisplatin in patients with para-aortic or high common iliac lymph
node-positive carcinoma of the uterine cervix.
- Determine the feasibility and tolerability of this regimen with the addition of
amifostine in these patients.
- Determine the efficacy of these 2 regimens, in terms of improving pelvic and
para-aortic tumor control and distant metastases, in these patients.
OUTLINE:
- Phase I: Patients undergo external beam radiotherapy to the pelvis and para-aortic
region 5 days a week for 5 weeks. Patients also undergo either intracavitary low-dose
rate (LDR) brachytherapy in 2 applications beginning within 2 weeks after completion of
external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate
intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam
radiotherapy. Patients also receive cisplatin IV over 1 hour weekly for 6 weeks
concurrently with external beam radiotherapy and once with LDR brachytherapy. Phase II
proceeds only if toxicity in phase I is within expected parameters.
- Phase II: Patients receive external beam radiotherapy, brachytherapy, and cisplatin as
in phase I. Patients also receive amifostine subcutaneously daily just before external
beam radiotherapy and cisplatin. Treatment continues for up to 8 weeks in the absence
of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40-66 patients (27 for phase I and 13-39 for phase II) will be
accrued for this study within 12-30 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven, locally advanced carcinoma of the uterine cervix
- TNM classification stage IIIB or IVA
- Disease metastatic to para-aortic or high common iliac lymph nodes
- Prior complete surgical resection of involved lymph nodes or gross residual
tumor involvement of a lymph node allowed
- The following cellular types are eligible:
- Squamous cell carcinoma
- Adenocarcinoma
- Adenosquamous carcinoma
- The following cellular types are ineligible:
- Small cell carcinoma
- Carcinoid tumor
- Glassy cell carcinoma
- Clear cell carcinoma
- Cystadenocarcinoma
- No metastatic disease outside of the pelvis (except to the para-aortic nodes)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- At least 6 months
Hematopoietic
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- ALT no greater than 2 times normal
Renal
- Creatinine no greater than 1.5 mg/dL (urinary diversion allowed)
- Corrected calcium normal
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent significant medical condition that would preclude study participation
- No insulin-dependent diabetes
- No other malignancy within the past 3 years except cutaneous basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic irradiation except transvaginal radiotherapy to control bleeding
Surgery
- See Disease Characteristics
- No prior tumor-directed surgery except lymph node biopsy/staging
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility and tolerability
Outcome Time Frame:
From start of treatment to 90 days
Safety Issue:
Yes
Principal Investigator
William Small, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
RTOG-0116
NCT ID:
NCT00012012
Start Date:
August 2001
Completion Date:
Related Keywords:
- Cervical Cancer
- Radiation Toxicity
- radiation toxicity
- stage III cervical cancer
- stage IVA cervical cancer
- cervical squamous cell carcinoma
- cervical adenocarcinoma
- cervical adenosquamous cell carcinoma
- Uterine Cervical Neoplasms
- Radiation Injuries
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| Mercy Cancer Institute at Mercy Hospital | Pittsburgh, Pennsylvania 15219 |
| Florida Oncology Associates at Southside Cancer Center | Jacksonville, Florida 32207 |
| Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
| Baptist Medical Center South | Jascksonville, Florida 32258 |
| Florida Oncology Associates | Orange Park, Florida 32073 |
| Florida Cancer Center - Palatka | Palatka, Florida 32177 |
| Flagler Cancer Center | Saint Augustine, Florida 32086 |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
