Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2013
• Main ID: NCT00054067
• Date of registration: 05/02/2003
• Primary sponsor: Gynecologic Oncology Group
• Public title: Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
• Scientific title: Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation
• Date of first enrolment: February 2003
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00054067
• Study type: Interventional
• Study design: Allocation: Randomized, Primary Purpose: Treatment

Countries of recruitment

Japan, United States

Contacts

• Name: D. Scott McMeekin, MD
• Affiliation: Oklahoma University Cancer Institute

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of
the following types:

- Squamous cell carcinoma

- Adenocarcinoma

- Adenosquamous carcinoma

- Primary, previously untreated disease

- Exophytic cervical lesions greater than 4 cm in diameter OR

- Cervical expansion to greater than 4 cm in diameter, presumed to be the result of
principal involvement with cancer

- No evidence of extrauterine disease other than pelvic lymph node involvement (by
clinical and radiographic examinations)

- No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission
tomography, or lymphangiogram) unless nodes are confirmed to be pathologically
negative (by CT-guided biopsy or extraperitoneal lymph node dissection)

- Eligible for radical hysterectomy and lymph node dissection

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal

Renal

- Creatinine no greater than 2.0 mg/dL

- No renal abnormalities requiring modification of radiation fields

Gastrointestinal

- No gastrointestinal bleeding

- No intestinal obstruction

Other

- Not pregnant

- Negative pregnancy test

- No septicemia or severe infection

- No other invasive malignancy with any evidence of disease within the past 5 years
except nonmelanoma skin cancer

- No circumstances that would preclude study completion or required follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

- No prior hysterectomy (total or subtotal)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Cancer

Intervention(s)

Drug: cisplatin

Procedure: adjuvant therapy

Procedure: conventional surgery

Radiation: brachytherapy

Radiation: radiation therapy

Secondary ID(s)

CDR0000269821

GOG-0201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)