Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care, Treatment	Closed	18 and over	NCI	RTOG-C-0116 RTOG-0116, NCT00012012

Objectives

1. Determine the feasibility and tolerability of external beam radiotherapy, brachytherapy, and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix.
2. Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients.
3. Determine the efficacy of these 2 regimens, in terms of improving pelvic and para-aortic tumor control and distant metastases, in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven, locally advanced carcinoma of the uterine cervix
  • TNM classification stage IIIB or IVA
  • Disease metastatic to para-aortic or high common iliac lymph nodes
    • Prior complete surgical resection of involved lymph nodes or gross residual tumor involvement of a lymph node allowed
  • The following cellular types are eligible:
    • Squamous cell carcinoma
    • Adenocarcinoma
    • Adenosquamous carcinoma
  • The following cellular types are ineligible:
    • Small cell carcinoma
    • Carcinoid tumor
    • Glassy cell carcinoma
    • Clear cell carcinoma
    • Cystadenocarcinoma
• No metastatic disease outside of the pelvis (except to the para-aortic nodes)

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior systemic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic irradiation except transvaginal radiotherapy to control bleeding

Surgery

• See Disease Characteristics
• No prior tumor-directed surgery except lymph node biopsy/staging

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• At least 6 months

Hematopoietic

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• ALT no greater than 2 times normal

Renal

• Creatinine no greater than 1.5 mg/dL (urinary diversion allowed)
• Corrected calcium normal

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No concurrent significant medical condition that would preclude study participation
• No insulin-dependent diabetes
• No other malignancy within the past 3 years except cutaneous basal cell skin cancer

Expected Enrollment

A total of 40-66 patients (27 for phase I and 13-39 for phase II) will be accrued for this study within 12-30 months.

Outcomes

Feasibility and tolerability
Toxicity

Pelvic tumor control
Distant metastases

Outline

• Phase I: Patients undergo external beam radiotherapy to the pelvis and para-aortic region 5 days a week for 5 weeks. Patients also undergo either intracavitary low-dose rate (LDR) brachytherapy in 2 applications beginning within 2 weeks after completion of external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam radiotherapy. Patients also receive cisplatin IV over 1 hour weekly for 6 weeks concurrently with external beam radiotherapy and once with LDR brachytherapy. Phase II proceeds only if toxicity in phase I is within expected parameters.
• Phase II: Patients receive external beam radiotherapy, brachytherapy, and cisplatin as in phase I. Patients also receive amifostine subcutaneously daily just before external beam radiotherapy and cisplatin. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Small W, Winter K, Levenback C, et al.: Extended field irradiation and intracavitary brachytherapy combined with cisplatin chemotherapy for cervical cancer with positive para-aortic or high common iliac lymph nodes: results of arm 2 of RTOG 0116. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-10, S5-6, 2007.

Small W Jr, Winter K, Levenback C, et al.: Extended-field irradiation and intracavitary brachytherapy combined with cisplatin chemotherapy for cervical cancer with positive para-aortic or high common iliac lymph nodes: results of ARM 1 of RTOG 0116. Int J Radiat Oncol Biol Phys 68 (4): 1081-7, 2007.[PUBMED Abstract]

Small W, Winter K, Levenback C, et al.: Extended field irradiation and intracavitary brachytherapy combined with cisplatin chemotherapy for cervical cancer with positive para-aortic or high common illiac lymph nodes: results of arm 1 of RTOG 0116. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-156, S94, 2005.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

William Small, MD, Protocol chair		Ph: 312-926-6810 Email: w-small@northwestern.edu

Registry Information
Official Title		A Two Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy (Weekly Cisplatin-Arm1) And Amifostine (Arm 2) In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes
Trial Start Date		2001-08-24
Registered in ClinicalTrials.gov		NCT00012012
Date Submitted to PDQ		2001-01-02
Information Last Verified		2007-02-25
NCI Grant/Contract Number		CA21661

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