Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer
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.
Radiation: intensity-modulated radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||DEPICT: A Phase I/II, Multi-Center Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer|
- Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v 3.0 [ Designated as safety issue: Yes ]
- Response rate assessed radiologically at 3 and 12 months [ Designated as safety issue: No ]
- Local control of the disease at 2 years [ Designated as safety issue: No ]
- Late toxicity at 2 years as defined by CTCAE v 3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||July 2010|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|London, England, United Kingdom, W12 0HF|
|Contact: Contact Person 44-20-8383-1000|
|Royal Marsden - London||Recruiting|
|London, England, United Kingdom, SW3 6JJ|
|Contact: Contact Person 44-20-7808-2581|
|Saint Bartholomew's Hospital||Recruiting|
|London, England, United Kingdom, EC1A 7BE|
|Contact: Contact Person 44-20-7882-8490 firstname.lastname@example.org|
|Principal Investigator:||Melanie Powell||St. Bartholomew's Hospital|