Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer
Summary
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.
Timeline
- Start
- 2000-06
- Primary completion
- 2007-11
- Completion
- 2016-12
Outcome
Missed primary endpoint
paper There was no statistically significant difference in the primary endpoint of local-regional failure (LRF) rate between the treatment arms. PMID 17716826 ↗
paper The 3-year LRF rate was 36% for control and 44% for Epo (p = 0.56). PMID 17716826 ↗
Publications
- Results Machtay 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.
- Results Machtay 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 40000 iu | Subcutaneous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |