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
- 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.
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility and tolerability
From start of treatment to 90 days
William Small, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|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|