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Clinical Trials (PDQ®)

Phase III Randomized Trial of Radiosensitization with HU vs HU/5-FU/CDDP vs CDDP in Patients with Stage IIB/III/IVA Cervical Cancer with Negative Para-Aortic Nodes
Last Modified: 4/8/2011  

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedany ageNCIGOG-120
GOG-0120

Objectives

I.  Determine which of the following treatments is superior in potentiating 
radiotherapy for locally advanced cervical carcinoma:  hydroxyurea (HU); 
HU/fluorouracil with bolus cisplatin (CDDP); or weekly CDDP.

II.  Determine the relative toxicities of these treatments when given 
concurrently with radiotherapy.

Entry Criteria

Disease Characteristics:


Histologically confirmed primary invasive carcinoma of the uterine cervix of
one of the following histologies:
  Squamous cell carcinoma
  Adenocarcinoma
  Adenosquamous carcinoma

Previously untreated Stage IIB/IIIA/IIIB/IVA disease with negative para-aortic
nodes
  Extraperitoneal para-aortic lymphadenectomy required
  Pelvic lymphadenectomy not required

No known intraperitoneal disease

Radiotherapy must begin within 6 weeks of surgery


Prior/Concurrent Therapy:


Biologic therapy:
  No prior biologic therapy

Chemotherapy:
  No prior cytotoxic chemotherapy

Endocrine therapy:
  No prior endocrine therapy

Radiotherapy:
  No prior pelvic irradiation

Surgery:
  Para-aortic lymphadenectomy required


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:
  No septicemia or severe infection
  No other condition that would interfere with completion of the study
  No past or current second malignancy except nonmelanomatous skin cancer
  No pregnant women


Expected Enrollment

90 patients/year will be entered over approximately 5.5 years.

Outline

Randomized study.

Arm I:  Radiotherapy with Single-Agent Radiosensitization.  External-beam 
irradiation with photon energies of at least 4 MeV plus intracavitary 
irradiation using radium, cesium, or cobalt sources; with Cisplatin, CDDP, 
NSC-119875.

Arm II:  Radiotherapy with 3-Drug Radiosensitization.  External-beam plus 
intracavitary irradiation as in Arm I; with Fluorouracil, 5-FU, NSC-19893; 
CDDP; Hydroxyurea, HU, NSC-32065.

Arm III:  Radiotherapy with Single-Agent Radiosensitization.  External-beam 
plus intracavitary irradiation as in Arm I; with HU.

Published Results

Rose PG, Ali S, Watkins E, et al.: Long-term follow-up of a randomized trial comparing concurrent single agent cisplatin, cisplatin-based combination chemotherapy, or hydroxyurea during pelvic irradiation for locally advanced cervical cancer: a Gynecologic Oncology Group Study. J Clin Oncol 25 (19): 2804-10, 2007.[PUBMED Abstract]

Rose PG, Bundy BN, Watkins EB, et al.: Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med 340 (15): 1144-53, 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]

Kunos C, Tian C, Waggoner S, et al.: Retrospective analysis of concomitant Cisplatin during radiation in patients aged 55 years or older for treatment of advanced cervical cancer: a gynecologic oncology group study. Int J Gynecol Cancer 19 (7): 1258-63, 2009.[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]

Monk BJ, Tian C, Rose PG, et al.: Which clinical/pathologic factors matter in the era of chemoradiation as treatment for locally advanced cervical carcinoma? Analysis of two Gynecologic Oncology Group (GOG) trials. Gynecol Oncol 105 (2): 427-33, 2007.[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.

Rose PG: Combined-modality therapy of locally advanced cervical cancer. J Clin Oncol 21 (10 Suppl): 211-7, 2003.

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

Peter Rose, MD, Protocol chair (Contact information may not be current)
Ph: 216-844-5432; 800-641-2422

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.