Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cisplatin Type: Drug
Name: intensity-modulated radiation therapy Type: Radiation
Overall Status
Recruiting
Summary
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of cisplatin given together with radiation therapy in treating patients with locally advanced cervical cancer.
Detailed Description
OBJECTIVES:

Primary

- To determine the feasibility of dose-escalation of chemoradiotherapy comprising cisplatin in combination with simultaneous-boost intensity-modulated radiotherapy (IMRT) in patients with locally advanced cervical cancer.

Secondary

- To assess the objective response rates in patients treated with this regimen.

- To assess the local control of the disease in patients treated with this regimen.

- To correlate toxicity with dose-volume histogram data in these patients.

OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study.

Patients receive cisplatin IV over 1 hour weekly for up to 5 weeks. Patients also undergo intensity-modulated radiotherapy 5 days a week for approximately 6 weeks.

Patients complete a quality-of-life questionnaire at baseline, during, and after completion of study therapy.

After completion of study treatment, patients are followed up at 4 and 12 weeks, every 3 months for 2 years, and then periodically for 5 years.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
Criteria: DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma, adenocarcinoma, or poorly differentiated carcinoma of the cervix

- Locally advanced disease

- FIGO stage IIB-IVA (any pelvic nodal status) or FIGO stage IB2 and IIA (with pelvic nodal involvement)

- Measurable disease on MRI scan

- No evidence of common iliac or para-aortic nodal involvement

- No distant metastases

PATIENT CHARACTERISTICS:

- WHO performance status 0-1

- Platelet count > 100 x 10^9/L

- White cell count > 3.0 x 10^9/L

- Neutrophil count > 1.5 x 10^9/L

- ALT/AST < 2.5 times upper limit of normal (ULN)

- Bilirubin < 1.25 times ULN

- EDTA clearance > 55 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior cancer except skin tumor

- No prior pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease, or diabetes mellitus

PRIOR CONCURRENT THERAPY:

- No prior pelvic radiotherapy or surgery other than laparoscopic node dissection

- No other concurrent anticancer or investigational therapy
Locations
Hammersmith Hospital
London, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-20-8383-1000
Royal Marsden - London
London, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-20-7808-2581
Saint Bartholomew's Hospital
London, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-20-7882-8490 - melanie.powell@bartsandthelondon.nhs.uk
Start Date
July 2010
Sponsors
St. Bartholomew's Hospital
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page