Clinical trial · Interventional
Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer
A Randomized Phase III Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiotherapy for Carcinoma of the Head and Neck
- 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)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and treat anemia in patients with head and neck cancer. It is not yet known whether receiving radiation therapy with epoetin alfa is more effective than radiation therapy alone in treating anemic patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating anemic patients who have head and neck cancer.
Conditions
Conditions (2)
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 | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| epoetin alfa | Biological | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive squamous cell carcinoma of the head and neck, including carcinoma arising from the oral cavity, oropharynx, larynx, and hypopharynx * Stage I-IV disease * No distant metastases * No carcinoma of the nasopharynx, nasal cavity/paranasal sinuses, or salivary glands * No carcinoma in situ without an identifiable invasive component * Plan for radiotherapy in continuous course * Prior surgical exploration with gross residual disease remaining allowed * Prior neck dissection with or without biopsy of primary tumor, but no radical surgery for primary tumor, allowed * Anemia, defined as hemoglobin no greater than 13.5 g/dL for males and no greater than 12.5 g/dL for females (transfusion prior to study allowed) * No severe anemia (i.e., hemoglobin less than 9.0 g/dL) * No anemia confirmed to be due to causes other than chronic disease (e.g., iron deficiency anemia) * Not entered on other RTOG head and neck protocols PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Stage III/IV patients receiving concurrent cisplatin: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * Stage III/IV patients receiving concurrent cisplatin: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 50 mL/min Cardiovascular: * No malignant or poorly controlled hypertension (e.g., symptomatic hypertension or diastolic blood pressure of 100 mm Hg or greater despite antihypertensive medication) * No unstable angina or other poorly controlled cardiac disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * If stage III or IV disease is present, willing to come for twice daily radiotherapy for the last 2.5 weeks of therapy * No active infection requiring IV antibiotics * No unexplained fever * No AIDS or other history of congenital or acquired immunodeficiency * No other malignancies within the past 3 years except carcinoma in situ or nonmelanomatous skin cancer * No known hypersensitivity to mammalian cell-derived products or to human albumin * No acute/subacute illness that would make the need for transfusion likely PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since other prior cytokine therapy (e.g., filgrastim \[G-CSF\], interleukins, or interferons) * No prior epoetin alfa * No other concurrent cytokine therapy Chemotherapy: * No prior chemotherapy * Concurrent cisplatin, paclitaxel/cisplatin, or paclitaxel/carboplatin for patients with stage III/IV disease is allowed Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy to the head and neck Surgery: * See Disease Characteristics Other: * No concurrent amifostine * No concurrent transfusion
References
Publications (2)
- RESULTMachtay M, Pajak TF, Suntharalingam M, Shenouda G, Hershock D, Stripp DC, Cmelak AJ, Schulsinger A, Fu KK; Radiation Therapy Oncology Group. Radiotherapy with or without erythropoietin for anemic patients with head and neck cancer: a randomized trial of the Radiation Therapy Oncology Group (RTOG 99-03). Int J Radiat Oncol Biol Phys. 2007 Nov 15;69(4):1008-17. doi: 10.1016/j.ijrobp.2007.04.063. Epub 2007 Aug 23. PMID 17716826
- RESULTMachtay M, Pajak T, Suntharalingam M, et al.: Definitive radiotherapy +/- erythropoietin for squamous cell carcinoma of the head and neck: preliminary report of RTOG 99-03. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-5, S132, 2004.