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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

Phase 3
Not Enrolling
Cervical Cancer

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Trial Information

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Rachelle M. Lanciano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Delaware County Regional Cancer Center at Delaware County Memorial Hospital


United States: Federal Government

Study ID:




Start Date:

October 1997

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage III cervical cancer
  • stage IIB cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms



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Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
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University of Rochester Cancer CenterRochester, New York  14642
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Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
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Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
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Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
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CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
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CCOP - Montana Cancer ConsortiumBillings, Montana  59101
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