Clinical trial · Interventional
Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
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
NCT00017004CI-TRIAL-00028999completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Drug Toxicity | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Stage IIB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Cervical Cancer | Malignant Cervical Neoplasm |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Epoetin Alfa | Biological | — | UNRESOLVED |
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Internal Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Radiation: External Beam Radiation Therapy
- Drug: Cisplatin
- Radiation: Internal Radiation Therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy.
- interventionNames
- Radiation: External Beam Radiation Therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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 patients must use effective contraception * See Disease Characteristics * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.