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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4
Study Overview
Brief 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.
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment (TEMLA and SBRT)
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.
Intervention: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT) (Combination Product)
Treatment (TEMLA and SBRT)
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.
Intervention: quality-of-life assessment (Other)
Outcomes
Primary Outcomes
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
Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.
Secondary Outcomes
- Time until chemotherapy(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(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(Up to 5 years)
- Overall survival(From SBRT completion until death, assessed up to 5 years)