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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
Not Enrolling
Anemia, Cervical Cancer, Drug/Agent Toxicity by Tissue/Organ, Radiation Toxicity

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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


- 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


- 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

- No involvement of the lower third of vagina

- No carcinoma of the cervical stump



- Not specified

Performance status:

- GOG 0-3

Life expectancy:

- Not specified


- See Disease Characteristics

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

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


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal


- Creatinine no greater than 2.0 mg/dL


- No uncontrolled hypertension

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

- No active hemolysis


- No history of pulmonary embolism


- 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


Biologic therapy:

- Not specified


- See Disease Characteristics

Endocrine therapy:

- Not specified


- See Disease Characteristics


- Not specified

Type of Study:


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


United States: Federal Government

Study ID:




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



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