About this trial
The aim of the study is to test the feasibility \& loco-regional control rate by combining high precision SBRT with chemotherapy in stage III NSCLC in tumor/lymph nodes if tumors/lymph node size with ≤ 6cms in size.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 or above and less than 75 years.
Histologically proven non-small cell lung cancer.
Stage T1-4, N1-3, M0 with maximum tumor size less than 6 cms and ≤ 3 stations of largest lymph node size less than 4 cms.
ECOG status 0-1.
Disqualifiers
Metastatic disease.
Tumor size > 6cm.
Involved Lymph node size greater than 4 cms & more than 3 station of lymph nodes involved.
Patients with superior vena cava obstruction.
Trial design
Single group
Treatments tested in this trial
SBRT in stage III NSCLC
RadiationSBRT to primary tumor and lymph nodes in stage III NSCLC when gross disease is \< 6 cms
Treatment groups
Trial outcomes
Primary outcomes
Loco-regional control rate
Loco regional control rate assessment till 2 years
Secondary outcomes
Disease free survival
Longitudinal assessment every 2 months for initial six months and every 3 months till next 2 years
Overall survival
Longitudinal assessment every 2 months for initial six months and every 3 months till next 2 years
CTCAE V5 Toxicity
CTCAE Grades Grade refers to the severity of the adverse event. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Assessed at base line, post SBRT, post Chemotherapy, first follow up, at 6 months and then 6 monthly
EORTC QLQ C30 Quality of life
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Assessed at base line, post SBRT, post Chemotherapy, first follow up, at 6 months and then 6 monthly
Sponsors and contacts
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