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Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 G/L With Erythropoietin Versus Above 100 G/L Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer


Phase 3
N/A
N/A
Not Enrolling
Female
Anemia, Cervical Cancer, Drug/Agent Toxicity by Tissue/Organ, Radiation Toxicity

Thank you

Trial Information

Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 G/L With Erythropoietin Versus Above 100 G/L Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer


OBJECTIVES:

- Assess the efficacy of raising and maintaining hemoglobin (Hgb) levels above 12.0 g/dL
with epoetin alfa vs maintaining Hgb levels above 10.0 g/dL without epoetin alfa on
progression-free survival, overall survival, and local control in anemic patients with
cervical cancer receiving concurrent radiotherapy and cisplatin.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to stage (IIB vs IIIB
vs IVA), method of brachytherapy (low-dose vs high-dose), and surgical staging of
para-aortic nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily
five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate
intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary
brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive
cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22,
29, and once during the week of parametrial boost radiotherapy.

- Arm II: Patients undergo radiotherapy and chemotherapy as in arm I. Additionally,
patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy
and chemotherapy.

Quality of life is assessed at baseline, during weeks 3 and 6, within 1 week of last
brachytherapy, and every 3 months for 2 years.

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

PROJECTED ACCRUAL: A total of 460 patients will be accrued for this study within 3.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or
adenosquamous carcinoma of the cervix

- Stage IIB, IIIB, or IVA

- Primary, previously untreated disease

- Hemoglobin less than 14 g/dL at presentation

- Negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT scan,
MRI, or lymphadenectomy

- Eligible for treatment with radical intent involving concurrent cisplatin and pelvic
radiotherapy

- No involvement of the lower third of vagina

- No carcinoma of the cervical stump

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-3

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

- Absolute neutrophil count at least 1,500/mm^3

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

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No uncontrolled hypertension

- No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial
infarction)

- No active hemolysis

Pulmonary:

- No history of pulmonary embolism

Other:

- No septicemia or severe infection

- No circumstances that would preclude study participation

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- No history of hypersensitivity to epoetin alfa or human albumin

- No diagnosis of vitamin B_12 or folic acid deficiency

- No recent (within the past 3 months) or uncontrolled seizure disorder

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook

Authority:

United States: Federal Government

Study ID:

CDR0000068641

NCT ID:

NCT00017004

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Anemia
  • Cervical Cancer
  • Drug/Agent Toxicity by Tissue/Organ
  • Radiation Toxicity
  • radiation toxicity
  • drug/agent toxicity by tissue/organ
  • stage III cervical cancer
  • stage IIB cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • anemia
  • Anemia
  • Uterine Cervical Neoplasms
  • Radiation Injuries

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
University of Colorado Cancer Center Denver, Colorado  80262
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
MBCCOP - Hawaii Honolulu, Hawaii  96813
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
Tacoma General Hospital Tacoma, Washington  98405
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
University of Texas Medical Branch Galveston, Texas  77555-1329
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
Cooper University Hospital Camden, New Jersey  08103
Barrett Cancer Center Cincinnati, Ohio  45267-0502
CCOP - M.D. Anderson Research Base Houston, Texas  77030-4009
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
Gynecologic Oncology of Middle Tennessee Nashville, Tennessee  37203