Stage IV Non-small Cell Lung Cancer Clinical Trial
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
Verified date | July 2022 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 14, 2020 |
Est. primary completion date | November 30, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 | Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals. | Up to 3 years | |
Secondary | Time until chemotherapy | A 90% confidence interval will be presented. | From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 5 years | |
Secondary | Incidence of toxicity associated with combining TEMLA with or without minimally invasive surgery stratified by chemotherapy regimens | Exact 90% confidence intervals will be obtained for each unique chemotherapy regimen. Will be compared at each time-point between tumor locations using the Fisher's exact test. | Up to 5 years | |
Secondary | Overall survival | Will be described using standard Kaplan-Meier methodologies. The median survival time, 3-year survival rate, and 5-year survival rate and will be estimated and presented with 90% confidence intervals. | From SBRT completion until death, assessed up to 5 years | |
Secondary | 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 | Will be compared with cumulative toxicity rates at each time-point between tumor locations using the Mann-Whitney U test. Comparisons of QoL scores between time-points will be made using the Wilcoxon signed rank test. | Up to 5 years |
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