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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00054067
First received: February 5, 2003
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.


Condition Intervention Phase
Cervical Cancer
Drug: cisplatin
Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: brachytherapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: February 2003
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy.
  • Compare the toxicity of these regimens in these patients.
  • Compare the health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: (Surgery followed by chemoradiotherapy): Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted.

    • Aborted hysterectomy: Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.

      • Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses.
      • Group 2: Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy.
      • Group 3: Patients receive further treatment at the discretion of the investigator.
    • Completed hysterectomy: Patients completing the radical hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.

      • Group A: Patients receive treatment as in group 1 above without intracavity irradiation.
      • Group B: Patients receive treatment as in group 2 above without intracavity irradiation.
      • Group C: Patients receive no further treatment.
  • Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses.

Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 7.5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054067

  Show 50 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: D. Scott McMeekin, MD Oklahoma University Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00054067     History of Changes
Other Study ID Numbers: CDR0000269821, GOG-0201
Study First Received: February 5, 2003
Last Updated: April 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
stage IB cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014