Return to List

Study Summary
No. RTOG C0116:.......Cervix......Anuja Jhingran......Radiation Oncology
.
Study Summary Title
Study Summary
Number:		RTOG C0116
Study Title:A 2-PART PHASE I/II STUDY OF EXTENDED FIELD EXTERNAL IRRADIATION & INTRACAVITARY BRACHYTHERAPY COMBINED W/CHEMO (WKLY CISPLATIN-ARM 1) & AMIFOSTINE (WKLY CISPLATIN & AMIFOSTINE-ARM 2)..
.
Physician New Patient Referral
Name:Anuja JhingranPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2972
Contact us about clinical trials
.
General Information
Disease Group:CervixSupported By:RTOG
Phase of Study:Phase I/Phase IIReturn
Visit:		During approx 7-8 wks of treatment, wkly pelvics & blood tests (appx 2 tsp) will be drawn. F/u every 3 mos for 1st two yrs, every 4 mos for 3rd yr, every 6 mos for 4th & 5th yr, and then annually.
Treatment
Agents:		Cisplatin
Ethiofos		Home Care:N/A
Treatment Loc:outpatient
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		Unavailable
.
Study Objectives / Outcomes
Unavailable
.
Study Status Information
Study Activation / Registration Date:11/26/2001
IRB Review and Approval Date:10/17/2001
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:45
.
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:Carcinoma of the uterine cervix with evidence of positive para-aortic or high common iliac lymph nodes. Still elig if lymph nodes have been completely resected or residual tumor of node remains.

Squamous cell, adenocarcinoma & adenosquamous carcinoma pts are elig.

No evidence of metastatic disease outside of the pelvis (except to the para-aortic nodes).

Zubrod status 0-1 & no significant medical contraindications to the administration of full dose chemo.

Signed informed consent.

WBC>/=3000/mm3 (ANC=1800/mm3); plts>/=100,000 mm3; creatinine </=1.5mg/dl (urinary diversion OK to improve renal function); bilirubin </=1.5mg/dl, ALT 2 x normal.
Exclusion Criteria:Prior (within 3 yrs) or simultaneous malignancies (other than cutaneous basal cell carcinoma or non-invasive tumors).

Pts with small cell, carcinoid, glassy cell, clear cell & adenoid cystic histologies.

Life expectancy < 6 months.

Pts with insulin dependent diabetes.

Previous systemic chemo: No pelvic radiation therapy permitted other than transvaginal irradiation to control bleeding.

Pregnant women and those of childbearing potential not using contraception.

Prior tumor-directed surgery with the exception of lymph node biopsies/staging.
.
Links
Registration Number:
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center