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Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix

This study is ongoing, but not recruiting participants.
Study NCT00012012.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix
Official Title  A Two Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy (Weekly Cisplatin-Arm1) And Amifostine (Arm 2) In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.

Detailed Description

OBJECTIVES:

  • Determine the feasibility and tolerability of external beam radiotherapy, brachytherapy, and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix.
  • Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients.
  • Determine the efficacy of these 2 regimens, in terms of improving pelvic and para-aortic tumor control and distant metastases, in these patients.

OUTLINE:

  • Phase I: Patients undergo external beam radiotherapy to the pelvis and para-aortic region 5 days a week for 5 weeks. Patients also undergo either intracavitary low-dose rate (LDR) brachytherapy in 2 applications beginning within 2 weeks after completion of external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam radiotherapy. Patients also receive cisplatin IV over 1 hour weekly for 6 weeks concurrently with external beam radiotherapy and once with LDR brachytherapy. Phase II proceeds only if toxicity in phase I is within expected parameters.
  • Phase II: Patients receive external beam radiotherapy, brachytherapy, and cisplatin as in phase I. Patients also receive amifostine subcutaneously daily just before external beam radiotherapy and cisplatin. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40-66 patients (27 for phase I and 13-39 for phase II) will be accrued for this study within 12-30 months.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure  Feasibility and tolerability [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Pelvic tumor control [ Designated as safety issue: No ]
Distant metastases [ Designated as safety issue: No ]
Condition  Cancer-Related Problem/Condition
Cervical Cancer
Intervention  Drug: amifostine trihydrate
Drug: cisplatin
Procedure: brachytherapy
Procedure: radiation therapy
MEDLINE PMIDs 17398031
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  66
Start Date  August 2001
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically proven, locally advanced carcinoma of the uterine cervix

    • TNM classification stage IIIB or IVA
    • Disease metastatic to para-aortic or high common iliac lymph nodes

      • Prior complete surgical resection of involved lymph nodes or gross residual tumor involvement of a lymph node allowed
    • The following cellular types are eligible:

      • Squamous cell carcinoma
      • Adenocarcinoma
      • Adenosquamous carcinoma
    • The following cellular types are ineligible:

      • Small cell carcinoma
      • Carcinoid tumor
      • Glassy cell carcinoma
      • Clear cell carcinoma
      • Cystadenocarcinoma
  • No metastatic disease outside of the pelvis (except to the para-aortic nodes)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • ALT no greater than 2 times normal

Renal

  • Creatinine no greater than 1.5 mg/dL (urinary diversion allowed)
  • Corrected calcium normal

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent significant medical condition that would preclude study participation
  • No insulin-dependent diabetes
  • No other malignancy within the past 3 years except cutaneous basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior systemic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior pelvic irradiation except transvaginal radiotherapy to control bleeding

Surgery

  • See Disease Characteristics
  • No prior tumor-directed surgery except lymph node biopsy/staging
Gender Female
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00012012
Organization ID CDR0000068472
Secondary IDs †† RTOG-C-0116
Study Sponsor  Radiation Therapy Oncology Group
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     William Small, MD     Robert H. Lurie Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date February 2007
First Received Date  March 3, 2001
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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