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Phase III Randomized Comparison of 5-FU/CACP vs HU As Potentiators of Radiotherapy in Patients with Stages IIB, III, and IVA Carcinoma of the Cervix with Negative Para-Aortic Nodes

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedany ageNCIGOG-85
SWOG-8695

Objectives

I.  Determine whether hydroxyurea or the combination of 
5-fluorouracil/cis-platinum is superior as a potentiator of radiotherapy in 
patients with Stages IIB, III, and IVA carcinoma of the cervix with negative 
para-aortic nodes.

II.  Compare response rates, time to progression, survival, and patterns of 
recurrence in these two patient groups.

III.  Compare the toxicities of these two chemotherapeutic regimens when 
administered concomitantly with radiotherapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients of any age with previously 
untreated, histologically confirmed invasive carcinoma of the cervix 
(squamous, adeno, or adenosquamous), Stages IIB, IIIA, IIIB, and IVA, provided 
they have had para-aortic lymphadenectomy and intraperitoneal exploration.  
The para-aortic nodes and cytologic washings must be negative for tumor, and 
there must be no evidence of intraperitoneal disease.  Pelvic lymphadenectomy 
is not a requirement for this protocol.  The WBC must be at least 3,000, 
platelets at least 100,000, creatinine not over 2.0 mg/dl, and alkaline 
phosphatase, bilirubin, and SGOT not over twice normal.  The GOG performance 
grade must be 3 or better.  There shall have been no previous or concomitant 
second malignancy aside from nonmelanomatous skin cancer, and patients must 
not have had prior cytotoxic chemotherapy or pelvic irradiation.  Septicemia 
and severe infection exclude.

Expected Enrollment

About 340 patients will be entered over about 3.5 years.

Outline

Randomized study.  Patients with Stage IIB disease receive Radiotherapy on 
Regimen A, while those with Stage III or IVA disease enter Regimen B.  All 
patients are randomized for concomitant Chemotherapy on Arms I and II.

Regimen A:  Radiotherapy.  External beam irradiation of all involved sites and 
associated nodal regions using x-rays of 4 MeV or greater or Co60, followed by 
intracavitary implantation (brachytherapy) using radium, cobalt, or cesium 
sources.  Total external beam dose is 4,080 cGy.

Regimen B:  Radiotherapy.  Irradiation of the same volume with the same 
modalities as in Regimen A.  Total external beam dose is 5,100 cGy.

Arm I:  2-Drug Combination Chemotherapy.  5-Fluorouracil, 5-FU, NSC-19893; 
cis-Platinum, CACP, NSC-119875.

Arm II:  Single-Agent Chemotherapy.  Hydroxyurea, HU, NSC-32065.

Published Results

Whitney CW, Sause W, Bundy BN, et al.: Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol 17 (5): 1339-48, 1999.[PUBMED Abstract]

Related Publications

Rose PG, Ali S, Whitney CW, et al.: Outcome of stage IVA cervical cancer patients with disease limited to the pelvis in the era of chemoradiation: a Gynecologic Oncology Group study. Gynecol Oncol 121 (3): 542-5, 2011.[PUBMED Abstract]

Rose PG, Ali S, Whitney CW, et al.: Impact of hydronephrosis on outcome of stage IIIB cervical cancer patients with disease limited to the pelvis, treated with radiation and concurrent chemotherapy: a Gynecologic Oncology Group study. Gynecol Oncol 117 (2): 270-5, 2010.[PUBMED Abstract]

Gold MA, Tian C, Whitney CW, et al.: Surgical versus radiographic determination of para-aortic lymph node metastases before chemoradiation for locally advanced cervical carcinoma: a Gynecologic Oncology Group Study. Cancer 112 (9): 1954-63, 2008.[PUBMED Abstract]

Gold M, Tian C, Whitney CW, et al.: Surgical versus radiologic exclusion of para-aortic lymph node metastases relative to chemoradiation for loco-regionally advanced cervical carcinoma: a meta-analysis of Gynecologic Oncology Group (GOG) protocols 85, 120 & 165. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-39, 2006.

Monaghan J: Time to add chemotherapy to radiotherapy for cervical cancer. Lancet 353 (9161): 1288-9, 1999.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Charles Whitney, MD, Protocol chair (Contact information may not be current)
Ph: 302-623-4500

Southwest Oncology Group

William Gordon, MD, PhD, Protocol chair
Ph: 281-332-7505

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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