Phase II Randomized controlled trial comparing conventionally fractionated radiation vs hypofractionated radiation in locally advanced non adeno non small cell carcinoma lung
- Conditions
- Health Condition 1: null- Cancer
- Registration Number
- CTRI/2013/11/004143
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
•Age less than 70 years.
•Confirmed HPE report of squamous cell or large cell carcinoma of lung
•Stage IIIA or IIIB
•KPS 70 or more.
•No prior treatment for lung cancer.
•All baseline investigation report within normal limit as indicated below:
1.HAEMOGRAM:
•Haemoglobin > 10 gram%
•Platelets count > 100,000/ cmm
•Total Leukocyte count > 4000/ cmm
•Absolute neutrophil count > 1500/ cmm
2.LIVER FUNCTION TEST:
•Total Bilirubin < 2mg%
•SGOT < 100 IU
•SGPT < 100IU
•ALP < 300IU
3.KIDNEY FUNCTION TEST:
•Blood urea < 50mg%
•Serum Creatinine < 1.5mg%
•Age more than 70 years.
•KPS less than 70.
•Any previous history of malignancy
•Synchronous malignancies
•Uncontrolled diabetes mellitus, uncontrolled systemic hypertension, severe COPD, CHF or chronic kidney disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To assess the feasibility of using hypofractionated radiotherapy with concurrent chemotherapy in locally advanced non-small cell lung cancer. <br/ ><br>â?¢To assess and compare the loco regional response and progression free survival. <br/ ><br>â?¢To evaluate the utility of PET scan in response evaluation of locally advanced NSCLC. <br/ ><br>Timepoint: at 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢To study and compare the toxicity of the two arms. <br/ ><br>â?¢Assess quality of life of patients undergoing treatment in both arms following EORTC protocol no.QLQ - LC 13. <br/ ><br>â?¢To compare the impact of overall treatment time in the management of locally advanced NSCLC (except adenocarcinoma). <br/ ><br>â?¢To assess and compare the overall survival in both arms <br/ ><br>Timepoint: at 6 months