Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical C… (NCT00017004) | Clinical Trial Compass
CompletedPhase 3
Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
United States114 participantsStarted 2001-08
Plain-language summary
Drugs used in chemotherapy 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. Epoetin alfa may stimulate red blood cell production to treat anemia in patients who have received chemotherapy and/or radiation therapy for cervical cancer. Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer.
Who can participate
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 radiotherapy
* No involvement of the lower third of vagina
* No carcinoma of the cervical stump
* Performance status - GOG 0-3
* 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 infarction)
* 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 pat…
What they're measuring
1
Progression-free survival with progression defined as a 50% or greater increase in the cross-product of the existing primary tumor relative to the smallest cross-product from all previous exams