Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Histopathologically proven non small cell lung cancer patients. 2.Unresectable lung cancers according to NCCN /BTS guidelines VI 3.Patients with adequate hematologic parameters hemoglobin HB >=10g/dl, total white blood cell (WBC) >= 4000/mm3 and platelets >= 100,000/mm3 )and renal function >= 60ml/min. 4. Patients with Eastern Cooperative Oncology Group (ECOG) performance status (0-2) 5.Patients having age 18-65 years. 6.Patients who are willing to give an approved informed consent
Exclusion criteria
Exclusion criteria: Patients who already treated with surgery ,radiation therapy or chemotherapy for ca lung. Patients with known distant metastases & malignant pleural effusion. Patients with (ECOG) performance status 3- 4 Clinically significant cardiovascular comorbidities. 5.Pregnant women and lactating mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AIM To evaluate tumor response and toxicities in unresectable non small cell lung cancers treated by concurrent chemo radiotherapy using two chemotherapy regimens such as cisplatin &etoposide vs carboplatin &paclitaxel. OBJECTIVES: To compare the following parameters between two arms(EP ARM & CP ARM). 1. Acute toxicities: (RTOG CRITERIA) a) Esophagitis b) Pneumonitis c )Hematological toxicities( anemia ,neutropenia, thrombocytopenia). 2. Tumor response rate: (RECIST CRITERIA) Timepoint: All patients will be reviewed on a weekly basis while the RT is going on, and on monthly basis after the completion of RT for a period of 6 months. During each clinical visit, patients will be assessed for severity of any acute or late toxicities including pneumonitis, esophagitis, and neutropenia, anemia, thrombocytopenia The follow up evaluations consist of patient history,a physical examination and a thoracic CECT at intervals of 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| AIM To evaluate tumor response and toxicities in unresectable non small cell lung cancers treated by concurrent chemo radiotherapy using two chemotherapy regimens such as cisplatin &etoposide vs carboplatin &paclitaxel. OBJECTIVES: To compare the following parameters between two arms(EP ARM & CP ARM). 1.Late toxicities: (RTOG CRITERIA after a period of 90 days a) Esophagitis b) PneumonitisTimepoint: All patients will be reviewed on a weekly basis while the RT is going on, and on monthly basis after the completion of RT for a period of 6 months. During each clinical visit, patients will be assessed for severity of any acute or late toxicities including pneumonitis, esophagitis, and neutropenia, anemia, thrombocytopenia The follow up evaluations consist of patient history,a physical examination and a thoracic CECT at intervals of 3 months. | — |
Countries
India
Contacts
Sri venkateswara institute of medical sciences