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

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00012012

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.

Condition	Intervention	Phase
Cervical Cancer Radiation Toxicity	Drug: amifostine trihydrate Drug: cisplatin Radiation: brachytherapy Radiation: radiation therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Cisplatin Amifostine

U.S. FDA Resources

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

Primary Outcome Measures:

Feasibility and tolerability [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pelvic tumor control [ Designated as safety issue: No ]
Distant metastases [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	August 2001
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.
Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients.
Determine the efficacy of these 2 regimens, in terms of improving pelvic and para-aortic tumor control and distant metastases, in these patients.

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.

PROJECTED ACCRUAL: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

At least 6 months

Hematopoietic

WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012012

Locations

United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Florida Oncology Associates at Southside Cancer Center
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States, 32250
Baptist Medical Center South
Jascksonville, Florida, United States, 32258
Florida Oncology Associates
Orange Park, Florida, United States, 32073
Florida Cancer Center - Palatka
Palatka, Florida, United States, 32177
Flagler Cancer Center
Saint Augustine, Florida, United States, 32086
United States, Michigan
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States, 08360
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309-2090
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Pennsylvania
Mercy Cancer Institute at Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

William Small, MD

Robert H. Lurie Cancer Center

More Information

Additional Information:

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

Publications:

Small W Jr, Winter K, Levenback C, Iyer R, Hymes SR, Jhingran A, Gaffney D, Erickson B, Greven K. Extended-Field Irradiation and Intracavitary Brachytherapy Combined With Cisplatin and Amifostine for Cervical Cancer With Positive Para-Aortic or High Common Iliac Lymph Nodes: Results of Arm II of Radiation Therapy Oncology Group (RTOG) 0116. Int J Gynecol Cancer. 2011 Sep 1; [Epub ahead of print]

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, Iyer R, Gaffney D, Asbell S, Erickson B, Jhingran A, Greven K. 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. 2007 Mar 28; [Epub ahead of print]

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.

Viswanathan AN, Moughan J, Small W Jr, Levenback C, Iyer R, Hymes S, Dicker AP, Miller B, Erickson B, Gaffney DK. The Quality of Cervical Cancer Brachytherapy Implantation and the Impact on Local Recurrence and Disease-Free Survival in Radiation Therapy Oncology Group Prospective Trials 0116 and 0128. Int J Gynecol Cancer. 2012 Jan;22(1):123-131.

ClinicalTrials.gov Identifier:	NCT00012012 History of Changes
Other Study ID Numbers:	CDR0000068472, RTOG-C-0116
Study First Received:	March 3, 2001
Last Updated:	January 5, 2012
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

radiation toxicity
stage III cervical cancer
stage IVA cervical cancer

cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Radiation Injuries
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

Wounds and Injuries
Cisplatin
Amifostine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012