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NRG-LU002

Trial

Clinical Trial Title

Maintenance Chemotherapy With or Without Stereotactic Body Radiation Therapy in Stage IV Non-small Cell Lung Cancer

Trial Status

Open to Enrollment

Start Date

July 17, 2017

Trial Type

Cancer - Adult Oncology

Specific Condition

Lung Cancer

Description

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

Eligibility Criteria

  • Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration. This includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop metastases
  • Age ≥ 18
  • Zubrod Performance Status 0, 1, or 2
  • Patients must have received first-line/induction systemic therapy (at least 4 cycles) and achieved stable disease or a partial response
  • Prior systemic therapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for other previous cancers is permitted
  • Prior radiotherapy for patients with brain metastases prior to enrollment is acceptable
     

Ineligibility Criteria

  • Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration after induction systemic therapy
  • Cutaneous metastasis of NSCLC
  • Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes
  • Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year
  • Metastases located within 3 cm of previously irradiated (< 3Gy per fraction) structures if:
  •     Spinal cord previously irradiated to > 40 Gy
  •     Brachial plexus previously irradiated to > 50 Gy
  •     Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
  •     Brainstem previously irradiated to > 50 Gy
  •     Lung previously irradiated with prior V20Gy > 35%

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 12:56:53 PM