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  • Last Modified: 11/1/2005

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Phase III Randomized Evaluation of Postoperative Radiotherapy vs No Further Treatment in Selected Patients with Stage IB Invasive Cervical Carcinoma

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedno age specifiedNCIGOG-49

Objectives

I.  Determine, by observing the 5-year survival and disease-free interval, the 
validity of current FIGO staging to the histopathologic factors of size of 
lesion, location of lesion, depth of invasion, histology and grade, growth 
pattern, and site and number of positive nodes in Stage IB carcinoma of the 
cervix.
II.  Accumulate prospectively significant surgical pathologic data that would 
expedite development of further protocols.
III.  Determine the morbidity of primary radical surgical therapy in these 
patients.
IV.  Determine whether radiotherapy improves survival in patients with 
unilateral metastasis to no more than 3 pelvic nodes when there is no 
parametrial involvement and there are clear vaginal margins.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients with 
histologically proven invasive Stage IB carcinoma of the cervix (squamous 
cell, adenocarcinoma, or adenosquamous).  There may be no past or concurrent 
malignancy aside from nonmelanomatous skin cancer.

Expected Enrollment

About 250-400 patients will be accrued annually, of whom about 10 percent will 
be eligible for the randomized portion of the study; the randomized part of 
the study will require 135 patients per arm over 8-9 years.  Protocol closed 
February 1984.

Outline

Randomized study.  Per April 1983 amendment, patients must be randomized no 
later than 8 weeks following surgery.
Regimen A:  Surgery.
Arm I:  Radiotherapy.  Co-60 teletherapy or other supervoltage treatment.
Arm II:  No further treatment.

Published Results

Whitney CW, Stehman FB: The abandoned radical hysterectomy: a Gynecologic Oncology Group Study. Gynecol Oncol 79 (3): 350-6, 2000.[PUBMED Abstract]

Delgado G, Bundy BN, Fowler WC Jr, et al.: A prospective surgical pathological study of stage I squamous carcinoma of the cervix: a Gynecologic Oncology Group Study. Gynecol Oncol 35 (3): 314-20, 1989.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

George Lewis, MD, Protocol chair
Ph: 215-955-8461; 800-533-3669
Email: 73522.1357@compuserve.com

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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