Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01230996
First received: October 28, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v 3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230996

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   
Sponsors and Collaborators
St. Bartholomew's Hospital
Investigators
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

ClinicalTrials.gov processed this record on October 01, 2014