Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: cisplatin Radiation: intensity-modulated radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 44 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Hammersmith Hospital | Recruiting |
| 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 melanie.powell@bartsandthelondon.nhs.uk | |
| Principal Investigator: | Melanie Powell | St. Bartholomew's Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01230996 History of Changes |
| Other Study ID Numbers: | CDR0000687340, BARTS-6883, EU-21079 |
| Study First Received: | October 28, 2010 |
| Last Updated: | October 28, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013