Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Completed | no age specified | NCI | GOG-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 Lead Organizations
Gynecologic Oncology Group
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| George Lewis, MD, Protocol chair | |
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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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