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A study to compare two chemotherapy regimens like cisplatin&etoposide vs paclitaxel&carboplatin with concurrent RT in non small cell lung cancers

A PROSPECTIVE STUDY TO COMPARE 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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036500
Enrollment
50
Registered
2021-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: Two arms each cispaltin vs etoposide & carboplatin& paclitaxel: All patients will be reviewed on a weekly basis while the RT is going on,along with councurrent chemo and on monthly basi

Sponsors

svims tirupati
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Rodda Yamini kumar

Sri venkateswara institute of medical sciences

ravibalasubramanian@hotmail.com9849692950

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026