Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer

Summary

RATIONALE: Amifostine may be an effective treatment for the toxic side effects caused by radiation therapy and chemotherapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine for non-small cell lung cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of amifostine in treating patients who have stage II or stage III non-small cell lung cancer that cannot be surgically removed and who are undergoing chemotherapy and radiation therapy.

Timeline

Start

1998-09

Primary completion

2002-07

Completion

2010-06

Publications

• Background Machtay M, Bae K, Movsas B, Paulus R, Gore EM, Komaki R, Albain K, Sause WT, Curran WJ. Higher biologically effective dose of radiotherapy is associated with improved outcomes for locally advanced non-small cell lung carcinoma treated with chemoradiation: an analysis of the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):425-34. doi: 10.1016/j.ijrobp.2010.09.004. Epub 2010 Oct 25.
• Background Siddiqui F, Bae K, Langer CJ, Coyne JC, Gamerman V, Komaki R, Choy H, Curran WJ, Watkins-Bruner D, Movsas B. The influence of gender, race, and marital status on survival in lung cancer patients: analysis of Radiation Therapy Oncology Group trials. J Thorac Oncol. 2010 May;5(5):631-9. doi: 10.1097/jto.0b013e3181d5e46a.
• Background Bruner DW. Outcomes research in cancer symptom management trials: the Radiation Therapy Oncology Group (RTOG) conceptual model. J Natl Cancer Inst Monogr. 2007;(37):12-5. doi: 10.1093/jncimonographs/lgm004.
• Background Langer CJ, Swann S, Curran W, et al.: Reassessing prognostic factors in the era of combined modality therapy for locally advanced NSCLC: a retrospective analysis of RTOG 9410 and 9801. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-65, S39, 2005.
• Background Machtay M, Swann S, Komaki R, et al.: What is the meaning of local-regional control after chemoradiation for locally advanced NSCLC? An RTOG analysis. [Abstract] Lung Cancer 50 (Suppl 2): A-O-041, S17, 2005.
• Background Sause W, Scott C, Byhardt R, et al.: Combined chemotheray radiation therapy treatment in unresected non-small cell lung cancer: Radiation Therapy Oncology Group (RTOG) experience. Lung Cancer 29(suppl 2): 2000.
• Results Movsas B, Moughan J, Sarna L, Langer C, Werner-Wasik M, Nicolaou N, Komaki R, Machtay M, Wasserman T, Bruner DW. Quality of life supersedes the classic prognosticators for long-term survival in locally advanced non-small-cell lung cancer: an analysis of RTOG 9801. J Clin Oncol. 2009 Dec 1;27(34):5816-22. doi: 10.1200/JCO.2009.23.7420. Epub 2009 Oct 26.
• Results Sarna L, Swann S, Langer C, Werner-Wasik M, Nicolaou N, Komaki R, Machtay M, Byhardt R, Wasserman T, Movsas B. Clinically meaningful differences in patient-reported outcomes with amifostine in combination with chemoradiation for locally advanced non-small-cell lung cancer: an analysis of RTOG 9801. Int J Radiat Oncol Biol Phys. 2008 Dec 1;72(5):1378-84. doi: 10.1016/j.ijrobp.2008.03.003. Epub 2008 May 22.
• Results Movsas B, Scott C, Langer C, Werner-Wasik M, Nicolaou N, Komaki R, Machtay M, Smith C, Axelrod R, Sarna L, Wasserman T, Byhardt R. Randomized trial of amifostine in locally advanced non-small-cell lung cancer patients receiving chemotherapy and hyperfractionated radiation: radiation therapy oncology group trial 98-01. J Clin Oncol. 2005 Apr 1;23(10):2145-54. doi: 10.1200/JCO.2005.07.167.
• Results Nicolaou N, Moughan J, Sarna L, et al.: Quality of life (QOL) supercedes the classic predictors of survival in locally advanced non-small cell lung cancer (NSCLC): an analysis of Radiation Therapy Oncology Group (RTOG) 9801. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-103, S58-59, 2007.
• Results Sarna L, Swann S, Langer C, et al.: Is there a "disconnect" between physician and patient - reported outcomes (PROs): an analysis of RTOG 98-01. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2595, S541, 2006.
• Results Werner-Wasik M, Langer C, Movsas B. Amifostine in chemoradiation therapy for non-small cell lung cancer: review of experience and design of a phase II trial assessing subcutaneous and intravenous bolus administration. Semin Oncol. 2005 Apr;32(2 Suppl 3):S105-8. doi: 10.1053/j.seminoncol.2005.03.018.
• Results Werner-Wasik M, Scott C, Movsas B, et al.: Amifostine as mucosal protectant in patients with locally advanced non-small cell lung cancer (NSCLC) receiving intensive chemotherapy and thoracic radiotherapy (RT): results of the radiation therapy oncology group (RTOG) 98-01 study. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S216, 2003.
• Results Movsas B. Exploring the role of the radioprotector amifostine in locally advanced non-small cell lung cancer: Radiation Therapy Oncology Group trial 98-01. Semin Radiat Oncol. 2002 Jan;12(1 Suppl 1):40-5. doi: 10.1053/srao.2002.31362.
• Lawrence YR, Paulus R, Langer C, Werner-Wasik M, Buyyounouski MK, Komaki R, Machtay M, Smith C, Axelrod RS, Wasserman T, Bradley JD, Movsas B. The addition of amifostine to carboplatin and paclitaxel based chemoradiation in locally advanced non-small cell lung cancer: long-term follow-up of Radiation Therapy Oncology Group (RTOG) randomized trial 9801. Lung Cancer. 2013 Jun;80(3):298-305. doi: 10.1016/j.lungcan.2013.02.008. Epub 2013 Mar 7.

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