Randomized phase II study of amifostine mucosal protection by either subcutaneous injection or rapid IV bolus for patients with inoperable stage II-IIIA/B or stage IV non-small cell lung cancer with oligometastases receiving concurrent radiochemotherapy with carboplatin and paclitaxel followed by optional consolidative chemotherapy: a follow-up study after RTOG 98-01

Semin Oncol. 2004 Dec;31(6 Suppl 18):47-51. doi: 10.1053/j.seminoncol.2004.12.012.

Abstract

While concurrent chemoradiotherapy is a standard treatment for good-performance patients with non-small cell lung cancer, acute esophagitis is a frequent toxicity. The incidence of severe acute esophagitis > or = grade 3 in patients treated with standard (once-daily) radiation therapy alone is 1.3%, increasing to 14% to 25% with the addition of concurrent chemotherapy, and 24% to 34% for the combination of hyperfractionated (twice-daily) radiation therapy plus concomitant chemotherapy. Although esophagitis is almost never a cause of mortality, it results in significant morbidity and may force treatment breaks, which are associated with inferior outcome in non-small cell lung cancer. Substantial investigative efforts to prevent or ameliorate esophagitis have been conducted. We describe herein the rationale/study design for a multi-institutional, phase II randomized study to evaluate either daily subcutaneous or intravenous bolus infusions of amifostine in patients with non-small cell lung cancer who receive standard fractionated thoracic radiation therapy concurrently with weekly paclitaxel and carboplatin chemotherapy.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Amifostine / administration & dosage
  • Amifostine / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carboplatin / administration & dosage
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / radiotherapy
  • Clinical Trials as Topic
  • Combined Modality Therapy
  • Follow-Up Studies
  • Humans
  • Injections, Subcutaneous
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / radiotherapy
  • Mucous Membrane / radiation effects
  • Radiation-Protective Agents / therapeutic use*

Substances

  • Radiation-Protective Agents
  • Carboplatin
  • Amifostine