RecruitingNot ApplicableNCT07565987
A Phase II Trial Evaluating Upfront Stereotactic Body Radiotherapy in Stage III Advanced Non-small Cell Lung Cancer
The APRIL Trial: A Phase II Trial Evaluating Upfront Stereotactic Body Radiotherapy in Stage III Advanced Non-small Cell Lung Cancer
Sponsor
All India Institute of Medical Sciences
Enrollment
20 participants
Start Date
Feb 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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.
- Available to attend long term follow- up.
- Written informed consent for treatment.
Exclusion Criteria13
- 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.
- Tumor invading/encasing the proximal bronchial tree/, esophagus, pericardium.
- Previous radiotherapy to thorax.
- Small cell histology.
- Age< 18 or > 75 years.
- Patients on anticoagulant therapy \& ultra-central cavitary tumors.
- Poor performance status ECOG 2-3.
- Immunocompromised states.
- Viral Markers negative.
- Pregnant women
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Interventions
RADIATIONSBRT in stage III NSCLC
SBRT to primary tumor and lymph nodes in stage III NSCLC when gross disease is \< 6 cms
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07565987
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