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

Basic Trial Information

Objectives

I.  Compare response rates and survival of patients with high-risk carcinoma 
of the cervix (Stages IIB-IVA and Stages IB and IIA with proven pelvic node 
involvement or tumors of 5 cm or greater) randomly assigned to standard-field 
pelvic irradiation plus concomitant fluorouracil/cisplatin vs. extended-field 
irradiation (pelvic plus para-aortic fields) without chemotherapy.

II.  Compare the toxicities of these 2 therapeutic regimens.

Entry Criteria

Disease Characteristics:

Histologically proven FIGO Stages IIB through IVA carcinoma
of the cervix

Stages IB and IIA disease included provided there is
biopsy-proven pelvic node involvement or tumor size of 5 cm
or greater

Acceptable histologies include:
  Squamous cell
  Adenocarcinoma
  Adenosquamous carcinoma

Excluded histologies:
  Small cell, carcinoid, glassy cell, clear cell, and adenoid
  cystic

No para-aortic lymph node involvement as determined by
bipedal lymphangiography or surgical exploration

  Biopsy confirmation, preferably by fine needle aspiration,
  required for suspicious or positive lymphangiogram

  Lymphangiogram strongly recommended prior to staging surgery

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior systemic chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No pelvic irradiation other than trans-vaginal to control
  bleeding

Surgery:
  No surgery other than exploratory laparotomy or biopsy

Patient Characteristics:

Age:
  Any age

Performance status:
  Karnofsky 60-100%

Life expectancy:
  At least 6 months

Hematopoietic:
  WBC greater than 4,000
  Platelets greater than 100,000
  Hb at least 10 g/dl

Hepatic:
  Bilirubin no greater than 1.5 mg/dl

Renal:
  Creatinine no greater than 1.5 mg/dl
  BUN no greater than 25 mg/dl
  (urinary diversion allowed to improve renal function)

Other:
  No insulin-dependent diabetes
  No HIV infection (HIV testing not required)
  No general medical problems to preclude full-dose
     chemotherapy
  No second malignancy except basal cell skin cancer

Expected Enrollment

400 patients will be entered over 3-4 years.

Outline

Randomized study.

Arm I:  Radiotherapy plus Radiosensitization with 2-Drug Combination 
Chemotherapy.  External-beam whole-pelvic irradiation using beams with 
energies of at least 4 MeV and intracavitary implants with radium or cesium; 
plus Fluorouracil, 5-FU, NSC-19893; Cisplatin, CDDP, NSC-119875.

Arm II:  Radiotherapy.  External-beam whole-pelvic and para-aortic irradiation 
and intracavitary implants with equipment as in Arm I.

Eifel PJ, Winter K, Morris M, et al.: Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol 22 (5): 872-80, 2004.[PUBMED Abstract]

Eifel PJ, Winter K, Morris M, et al.: Pelvic radiation with concurrent chemotherapy versus pelvic and para-aortic radiation for high-risk cervical cancer: an update of RTOG 90–01. [Abstract] Int J Radiat Oncol Biol Phys 54 (2 suppl 1): 1, 2002.

Morris M, Eifel PJ, Lu J, et al.: Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med 340 (15): 1137-43, 1999.[PUBMED Abstract]

Torres MA, Jhingran A, Thames HD Jr, et al.: Comparison of treatment tolerance and outcomes in patients with cervical cancer treated with concurrent chemoradiotherapy in a prospective randomized trial or with standard treatment. Int J Radiat Oncol Biol Phys 70 (1): 118-25, 2008.[PUBMED Abstract]

Wolfson AH, Winter K, Crook W, et al.: Are increased tumor aneuploidy and heightened cell proliferation along with heterogeneity associated with patient outcome for carcinomas of the uterine cervix? A combined analysis of subjects treated in RTOG 9001 and a single-institution trial. Int J Radiat Oncol Biol Phys 70 (1): 111-7, 2008.[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

Radiation Therapy Oncology Group

Mitchell Morris, MD, Protocol chair		Ph: 713-745-3000; 800-392-1611 Email: mmorris@mdanderson.org

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