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

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054067

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Cervical Cancer Surgery

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

February 2003

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

National Cancer Institute (NCI)

Investigators

Study Chair:

D. Scott McMeekin, MD

Oklahoma University Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000269821, GOG-0201
Study First Received:	February 5, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00054067 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
stage IB cervical cancer

Additional relevant MeSH terms:

Antineoplastic Agents
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Pharmacologic Actions
Uterine Cervical Neoplasms
Genital Diseases, Female

Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009