Overview

This trial is active, not recruiting.

Conditions recurrent non-small cell lung cancer, stage iiia non-small cell lung cancer, stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer
Treatments therapeutic lymphadenectomy, stereotactic radiosurgery, quality-of-life assessment
Sponsor Roswell Park Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date March 2013
End date November 2015
Trial size 10 participants
Trial identifier NCT01781741, I 223812, NCI-2013-00055, P30CA016056

Summary

This pilot clinical trial studies stereotactic body radiation therapy after surgery in treating patients with stage III-IV non-small cell lung cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with non-small cell lung cancer. Giving stereotactic body radiation therapy after lymphadenectomy may kill any tumor cells that remain after surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without minimally invasive surgery.
therapeutic lymphadenectomy
Undergo TEMLA
stereotactic radiosurgery
Undergo SBRT
quality-of-life assessment quality of life assessment
Ancillary studies

Primary Outcomes

Measure
Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4
time frame: Up to 3 years

Secondary Outcomes

Measure
Time until chemotherapy
time frame: From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 5 years
Incidence of toxicity associated with combining TEMLA with or without minimally invasive surgery stratified by chemotherapy regimens
time frame: Up to 5 years
Overall survival
time frame: From SBRT completion until death, assessed up to 5 years
Quality of life (QoL) scores from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ Lung Cancer-Specific Module
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 - Have histologically proven diagnosis of non-small cell lung cancer (NSCLC) (stage III and stage IV [to include limited volume metastases such as brain, bone, adrenal]) - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving and study related procedure - Patients with chemotherapy prior to TEMLA are eligible Exclusion Criteria: - Contraindication to SBRT or TEMLA; this includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly - If patient has an open thoracotomy for lung cancer they will not be able to receive SBRT and will be replaced - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which the investigator's opinion deems the patient ineligible - Received an investigational agent within 30 days prior to enrollment

Additional Information

Official title A Pilot Study of Stereotactic Body Radiation Therapy (SBRT) After TEMLA With or Without Minimally Invasive Surgery for Stage III and Stage IV (Oligometastatic) Non-small Cell Lung Cancer
Principal investigator Anurag Singh
Description PRIMARY OBJECTIVES: I. To assess the feasibility/toxicity of combining transcervical extended mediastinal lymphadenectomy (TEMLA) with or without video-assisted thoracoscopic surgery (VATS) and stereotactic body radiation therapy (SBRT). SECONDARY OBJECTIVES: I. To assess time to initiation of chemotherapy following TEMLA with or without video-assisted thoracoscopic surgery (VATS)and SBRT. II. To assess feasibility/toxicity of combining TEMLA with or without VATS and SBRT with various chemotherapy regimens (to be determined by medical oncologist based on patient and tumor characteristics). III. To estimate survival following TEMLA with or without VATS and SBRT. IV. To define any differences in quality of life/toxicity following TEMLA with or without VATS and SBRT based on tumor location (peripheral/central). V. To assess response for primary tumor control and overall survival in TEMLA only patients. VI. To assess progression free survival for TEMLA with or without (VATS) patients. OUTLINE: Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without VATS. After completion of study treatment, patients are followed up at 6,9, and 12 months, every 6 months for 2 years and annually for 2 years.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Roswell Park Cancer Institute.