Proton Beam Radiation Therapy and Cisplatin in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer and Positive Lymph Nodes

• Status: Withdrawn
• Trial end date: 2011-08-18
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Specialized radiation therapy, such as proton beam radiotherapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving proton beam radiation therapy together with cisplatin works in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer and positive lymph nodes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Cisplatin

Criteria

Inclusion

• Patients must have histologically documented carcinoma of the uterine cervix

• FIGO Stage IB to IVA

• Patients must have no distant metastases apart from positive lymph nodes by FDG PET

• Patients must have a Karnofsky Performance Status of >= 60

• Treatment plan includes cisplatin and patient has no medical contraindications to the administration of cisplatin

• Adequate bone marrow function: WBC >= 3000/mm^3; platelets >= 75,000 mm^3

• Adequate renal function: creatinine =< 2.0 mg/dl (urinary diversion is permitted to improve renal function)

• Patients must have bilirubin =< 1.5 mg/dl

• Ability to understand and the willingness to sign a written informed consent document

Exclusion

• FDG PET Scan evidence of distant disease

• No prior surgery for treatment of disease other than exploratory laparotomy or biopsy will be allowed

• No previous systemic chemotherapy will be allowed

• No prior pelvic radiation therapy is permitted other than transvaginal irradiation to control bleeding will be allowed

• Women of childbearing potential who have a positive result on screening serum pregnancy test