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Radiation Therapy With or Without Cisplatin or Fluorouracil in Treating Patients With Cancer of the Cervix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003078
Recruitment Status : Completed
First Posted : June 23, 2004
Last Update Posted : July 9, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE June 23, 2004
Last Update Posted Date July 9, 2013
Study Start Date  ICMJE October 1997
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy With or Without Cisplatin or Fluorouracil in Treating Patients With Cancer of the Cervix
Official Title  ICMJE A Randomized Comparison of Radiation vs Radiation Plus Weekly Cisplatin vs Radiation Plus PVI (Protracted Venous Infusion) 5-FU in Patients With Stage II-B, III-B, and IV-A Carcinoma of the Cervix With Negative Paraaortic Nodes
Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may kill more tumor cells. It is not known whether receiving radiation therapy plus cisplatin is more effective than receiving radiation therapy plus fluorouracil in treating patients with cancer of the cervix.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin or fluorouracil in treating patients with primary stage IIB, stage IIIB, or stage IVA cancer of the cervix.

Detailed Description

OBJECTIVES: I. Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis receiving either radiotherapy alone, or radiotherapy plus weekly cisplatin, or radiotherapy plus prolonged venous infusion (PVI) of fluorouracil. [Radiotherapy alone regimen closed 8/18/98] II. Determine the relative toxic effects of radiation therapy plus chemotherapy with either weekly cisplatin or PVI fluorouracil compared to radiation alone. [Radiotherapy alone regimen closed 8/18/98] IV. Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis and who smoke at the time of diagnosis versus non-smokers and those who smoke during radiation therapy versus those who quit.

OUTLINE: This is a randomized study. Patients are stratified by stage, performance of para-aortic lymphadenectomy, and brachytherapy method (HDR vs LDR). Prior to treatment patients complete a questionnaire regarding past and present smoking history and exposure to secondhand smoke. In arm I, patients undergo external radiation therapy to the pelvis once daily 5 times a week for 5 weeks. Then, patients receive either low dose rate or high dose rate intracavitary brachytherapy in one or two applications or 5 fractions once or twice a week, respectively. If intracavitary radiation therapy cannot be performed, then shrinking field technique is executed. In addition, patients receive parametrial boost once daily for 3 to 5 days during intracavitary brachytherapy. Concurrently, patients receive IV cisplatin once a week for 5 weeks beginning on day 1 of external radiation therapy and once during the parametrial boost. Patients in arm II receive external radiation therapy and brachytherapy as previously described. [Arm II closed 8/18/98] In arm III, patients undergo external radiation therapy as described in arm I. In addition, patients receive prolonged venous infusion (PVI) fluorouracil daily for 5 days during external beam radiation therapy (whole pelvis and parametrial boost). If all 6 courses of cisplatin or fluorouracil cannot be administered during external radiation therapy, then the sixth course of chemotherapy will be given during brachytherapy. Patients are followed every 3 months for the first 2 years, then every 6 months for the next 3 years, then annually until death.

PROJECTED ACCRUAL: This study will accrue a maximum of 870 patients over 66 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: cisplatin
  • Drug: fluorouracil
  • Radiation: brachytherapy
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February¬†15,¬†2007)
870
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix stage IIB, IIIB, or IVA Negative para-aortic lymph nodes determined by lymphangiogram, CT, MRI, or lymphadenectomy (excluding suspicious para-aortic lymph nodes) Para-aortic lymphadenectomy must be performed extraperitoneally or by laparoscopy No histologically confirmed cancer involving the para-aortic lymph nodes, intraperitoneal disease, or positive peritoneal cytology No recurrent invasive carcinoma of the uterine cervix, regardless of previous treatment or cervix cancers other than squamous cell, adenosquamous, or adenocarcinoma No carcinoma of the cervical stump

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT and alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: No septicemia or severe infection Not pregnant Negative pregnancy test Effective contraception required of fertile patients No other invasive malignancy unless disease free for at least 5 years and no prior cancer treatment that contraindicated this protocol therapy No concomitant malignancy other than nonmelanomatous skin cancer Must complete smoking history questionnaire and provide urine specimen for cotinine analysis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy to the pelvis Surgery: No prior hysterectomy

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003078
Other Study ID Numbers  ICMJE CDR0000065771
GOG-0165
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Rachelle M. Lanciano, MD Delaware County Regional Cancer Center at Delaware County Memorial Hospital
PRS Account Gynecologic Oncology Group
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP