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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Radiation Toxicity

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility and tolerability

Outcome Time Frame:

From start of treatment to 90 days

Safety Issue:

Yes

Principal Investigator

William Small, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

RTOG-0116

NCT ID:

NCT00012012

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Radiation Toxicity
  • radiation toxicity
  • stage III cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms
  • Radiation Injuries

Name

Location

Akron City HospitalAkron, Ohio  44304
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Cancer Treatment CenterWooster, Ohio  44691
Mercy Cancer Institute at Mercy HospitalPittsburgh, Pennsylvania  15219
Florida Oncology Associates at Southside Cancer CenterJacksonville, Florida  32207
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Baptist Medical Center SouthJascksonville, Florida  32258
Florida Oncology AssociatesOrange Park, Florida  32073
Florida Cancer Center - PalatkaPalatka, Florida  32177
Flagler Cancer CenterSaint Augustine, Florida  32086
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360