MDACC Study Summary ID01-545

Study Summary
No. ID01-545:.......Cervix......Anuja Jhingran......Radiation Oncology

Study Summary Title



Study Summary Number:	ID01-545

Study Title:	Acute Toxicity of Chemoradiation for Cervical Cancer

Physician

New Patient Referral



Name:	Anuja Jhingran	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Cervix	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	First and second years post therapy - every three months. Third - Sixth year - every six months, annually thereafter.

Treatment Agents:	5-FU Cisplatin	Home Care:	The continuous intravenous infusion of 5 Fu is given by a pump that will be on the patients for four days and will be taken home with the patient.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Three days x 2 for brachytherapy.


Description/ Intervention:	The goal of this clinical research study is to evaluate acute side effects and quality of life in two equally good chemoradiation therapy treatments for locally advance cervical cancer. Researchers also want to learn about acute side effects of chemoradiation.

Study Objectives / Outcomes

1. To evualate the acute toxicity of chemoradiation regimens in the treatment of locally advanced cervical cancer.
2. To determine the quality of life in patients receiving chemoradiation for locally advanced cervical cancer.

Study Status Information



Study Activation / Registration Date:	12/05/2001

IRB Review and Approval Date:	11/21/2001

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must have advanced carcinoma of the uterine cervix including FIGO Stage IIB through IVA. Patients with Stage IB or IIA and biopsy proven positive pelvic nodes or tumor size of 5 cm or greater are also eligible.

2) Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are eligible.

3) Patients who have been treated with a radical hysterectomy but need post-operative chemoradiation therapy due to high-risk factors.

4) Patients must have no evidence of metastatic disease outside of the pelvis.

5) Patients must have a Karnofsky Performance Status of >60 and no medical contraindications to the administration of chemotherapy.

6) Adequate bone marrow functions as defined as a hemoglobin > 10 mg/ml, WBC > 4000/mm3, platelets > 100,000/mm3. Adequate renal function as defined as BUN < 25 mg/dl, creatinine < 1.5 mg/dl (urinary diversion is permitted to improve renal function). Patients must have bilirubin < 1.5 mg/dl.

7) The patient must be able to understand the protocol and sign a study-specific informed consent. She must be able to have adequate social support to properly care for the infusion pump and indwelling catheter.

Exclusion Criteria:

1) Prior or simultaneous malignancies (other than cutaneous basil cell carcinoma).

2) Karnofsky Performance Status < 60.

3) Patients with significant medical illness preventing the use of full dose chemotherapy are excluded.

4) Patients with the following histologies are excluded: small cell, carcnoid, glassy cell, clear cell, and adenoid cystic.

5) Life expectancy < 6 months.

6) There will be no age restriction. Patients will be individually assessed regarding their ability to tolerate this treatment.

7) Patient known to be infected with HIV are not eligible. HIV testing is not a requirement for inclusion.

8) No prior surgery for treatment of disease other than exploratory laparotomy or biopsy.

9) FIGO Stage IVb disease.

10) Patients with para-aortic disease are not eligible.

11) No previous pelvic radiation therapy or systemic chemotherapy is permitted other than trans-vaginal irradiation to control bleeding.

Links

Registration Number: Not Applicable Clinical Trial