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Clinical Trials (PDQ®)

  • Last Modified: 2/14/2008

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Clinical Trials (PDQ®)

Phase III Pelvic vs Pelvic plus Para-Aortic Radiotherapy in Stage IIB or Bulky IB/IIA Cervical Carcinoma

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 to 75NCIRTOG-7920
RTOG-79-20

Objectives

I.  Determine the value of pelvic radiation vs. pelvic and para-aortic node 
irradiation when para-aortic nodes are clinically negative in Stage IIB, bulky 
Stage IB and IIA cervical carcinoma as measured by relapse-free survival and 
total survival.
II.  Determine the increased morbidity, if any, of extended para-aortic 
irradiation as against pelvic irradiation only in terms of early and late 
complications.
III.  Determine the superiority, if any, of various treatment techniques 
employed in para-aortic irradiation.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
FIGO Stage IIB or bulky Stage IB/IIA cervical carcinoma (without clinical 
evidence of para-aortic nodal involvement, April 1980 Revision) who have not 
undergone curative surgery or prior radiotherapy to the target site.  Patients 
must be between 18 and 75 years old with a Karnofsky performance status of 40 
or better.  Patients must have adequate bone marrow and renal status.

Expected Enrollment

364 patients will be entered in 6 years.

Outline

Randomized study.
Arm I:  Radiotherapy.  Pelvic irradiation using supervoltage equipment (Co-60 
or higher energy).
Arm II:  Radiotherapy.  Irradiation of the pelvis and para-aortic region.

Published Results

Rotman M, Pajak TF, Choi K, et al.: Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20. JAMA 274 (5): 387-93, 1995.[PUBMED Abstract]

Rotman M, Choi K, Guse C, et al.: Prophylactic irradiation of the para-aortic lymph node chain in stage IIB and bulky stage IB carcinoma of the cervix, initial treatment results of RTOG 7920. Int J Radiat Oncol Biol Phys 19 (3): 513-21, 1990.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Marvin Rotman, MD, Protocol chair
Ph: 718-270-2181
Email: mrotman@downstate.edu

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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