MDACC Study Summary RTOG 0116 (Archived)

Study Summary
No. RTOG 0116:.......Cervix......Anuja Jhingran......Radiation Oncology

Study Summary Title



Study Summary Number:	RTOG 0116

Study Title:	A TWO-PART PHASE I/II STUDY OF EXTENDED FIELD EXTERNAL IRRADIATION AND INTRACAVITARY BRACHYTHERAPY COMBINED WITH CHEMOTHERAPY (WEEKLY CISPLATIN–ARM 1) AND AMIFOSTINE (WEEKLY CISPLATIN AND AMIFOSTINE-ARM 2) IN CARCINOMA OF THE CERVIX WITH POSITIVE PARA-AORTIC OR HIGH COMMON ILIAC LYMPH NODES

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:	Phase I/Phase II	Return Visit:	During 7-8 wks of treatment,wkly pelvic exams/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,then annually.For efficacy,add'l follow ups after closure of accrual are needed.

Treatment Agents:	Cisplatin	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to learn if chemotherapy combined
with radiation can help to shrink or slow the growth of the tumor in women who
have cervical cancer. The safety of this treatment will also be studied. If
this treatment is found to be effective, then researchers will want to add
amifostine to the combination to learn if it can decrease side effects from the
combination of radiation and chemotherapy.

Study Objectives / Outcomes

To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin.

To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin in combination with amifostine.

3. To evaluate the efficacy of extended-field and intracavitary irradiation with weekly cisplatin +/- amifostine in improving pelvic and para-aortic tumor control and distant metastasis in carcinoma of the uterine cervix with positive para-aortic or high common iliac lymph nodes.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	10/18/2001

Study Type:

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:

1) Patients must have carcinoma of the uterine cervix with evidence for positive para-aortic or high common iliac lymph nodes (See Section 4.1.6). Patients remain eligible if the involved lymph nodes have been completely resected or if gross residual tumor involvement of a lymph node remains.

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

3) Patients must have no evidence of metastatic disease outside of the pelvis (except to the para-aortic nodes).

4) Patients must have a Zubrod Performance Status 0-1 and no significant medical contraindications to the administration of full dose chemotherapy.

5) Adequate bone marrow function: WBC > or equal to 3000/mm3 (ANC = 1800/mm3); platelets > or equal to 100,000 mm3; Adequate renal function: creatinine < or equal to 1.5 mg/dl (urinary diversion is permitted to improve renal function); patients must have bilirubin < or equal to 1.5 mg/dl, ALT 2 x normal, corrected calcium level within normal level.

6) Signed study-specific informed consent prior to study entry

Exclusion Criteria:

1) Prior (within the last 3 years) or simultaneous malignancies (other then cutaneous basal cell carcinoma or non-invasive tumors)

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

3) Life expectancy < 6 months

4) Patients with insulin dependent diabetes

5) Prior tumor-directed surgery other than lymph node biopsies/staging.

Links

Registration Number: NCT00012012
Study Information on Clinical Trials Registry (clinicaltrials.gov)