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Clinical Trials (PDQ®)

  • Last Modified: 6/17/2010

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Clinical Trials (PDQ®)

Phase III Randomized Study of Radiotherapy with vs without Weekly CDDP Followed by Adjuvant Hysterectomy in Patients with Bulky Stage IB Carcinoma of the Cervix

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedany ageNCIGOG-123
GOG-0123

Objectives

I.  Determine whether weekly cisplatin improves locoregional control and 
survival when added to a regimen of radiotherapy and adjuvant extrafascial 
hysterectomy in patients with bulky Stage IB carcinoma of the cervix.

II.  Determine the relative toxicities of radiotherapy plus cisplatin vs. 
radiotherapy alone in these patients.

Entry Criteria

Disease Characteristics:


Histologically confirmed, previously untreated, Stage IB carcinoma of the
cervix of one of the following histologies:
  Squamous cell carcinoma
  Adenocarcinoma
  Adenosquamous carcinoma

Bulky disease required, i.e., at least 4 cm or barrel shaped

Pelvic and para-aortic lymph nodes must be radiographically or surgically
negative
  Positive or suspicious lesions on CT scan or lymphangiogram require negative
  fine-needle aspiration cytology or histologic confirmation of negative nodes

Entry within 8 weeks of diagnosis required


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior systemic chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior pelvic irradiation

Surgery:
  No prior partial or total hysterectomy


Patient Characteristics:


Age:
  Any age

Performance status:
  GOG 0-3

Hematopoietic:
  WBC at least 3,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 x normal
  SGOT no greater than 3 x normal

Renal:
  Creatinine no greater than 2.0 mg/dl

Other:
  Able to undergo surgery and complete therapy and follow-up
  No prior or concomitant second malignancy except nonmelanomatous skin cancer


Expected Enrollment

317 patients will be entered at an estimated accrual rate of 55 patients/year.

Outline

Randomized study.

Arm I:  Radiotherapy followed by Surgery.  External beam irradiation using 
x-rays with a minimum energy of 4 MeV plus intracavitary irradiation using 
Cesium, Ce; followed by extrafascial hysterectomy.

Arm II:  Radiotherapy plus Radiosensitization/Chemotherapy followed by 
Surgery.  External beam plus intracavitary irradiation as in Arm I; plus 
Cisplatin, CDDP, NSC-119875; followed by extrafascial hysterectomy.

Published Results

Stehman FB, Ali S, Keys HM, et al.: Radiation therapy with or without weekly cisplatin for bulky stage 1B cervical carcinoma: follow-up of a Gynecologic Oncology Group trial. Am J Obstet Gynecol 197 (5): 503.e1-6, 2007.[PUBMED Abstract]

Keys HM, Bundy BN, Stehman FB, et al.: Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med 340 (15): 1154-61, 1999.[PUBMED Abstract]

Related Publications

Kunos C, Ali S, Abdul-Karim FW, et al.: Posttherapy residual disease associates with long-term survival after chemoradiation for bulky stage 1B cervical carcinoma: a Gynecologic Oncology Group study. Am J Obstet Gynecol 203 (4): 351.e1-8, 2010.[PUBMED Abstract]

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

Henry M. Keys, MD, Protocol chair
Ph: 518-262-6713
Email: keysh@mail.amc.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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