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NRG-CC003

Trial

Clinical Trial Title

A Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer

Trial Status

Closed to Enrollment

Start Date

December 6, 2015

Trial Type

Cancer - Adult Oncology

Specific Condition

Small Cell Lung Cancer

Description

This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.

Eligibility Criteria

Eligibility Criteria

  • Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration;
  •     High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.
  • Post-chemotherapy restaging imaging must be completed no more than 56 days prior to Step 1 registration.
  • For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted.
  • Zubrod performance status 0-2 within 30 days prior to Step 1 registration;

Ineligibility Criteria

  • Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields;
  • Radiographic evidence of CNS metastases;

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Andrew Kee, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:50 PM