A study to see effectiveness of chemotherapy for older patients with lung cancer.
- Conditions
- Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
- Registration Number
- CTRI/2022/07/044193
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age = 60 years
2. Histologically or cytologically confirmed non-small cell lung carcinoma (NSCLC).
3. Absence of sensitizing EGFR mutation and absence of EML4-ALK fusion. Patient is not planned for molecular targeted therapy, including EGFR-directed oral tyrosine kinase inhibitor or ALK-directed oral tyrosine kinase inhibitor. Patients with molecularly driven NSCLC who cannot receive molecularly targeted therapy for any reason and who are planned for first-line palliative intent chemotherapy will be eligible for the trial.
4. Planned for palliative intent chemotherapy in the first line.
5. ECOG PS 0 to 2 (on a 6-point scale ranging from 0 to 5, with higher scores indicating increasing disability; a score of 0 indicates no symptoms, 1 indicates mild symptoms and restricted in physically strenuous activities but ambulatory and able to do light work; and 2 indicates that the patient is ambulatory and capable of all selfcare but unable to do any work, and is up and about over half of the waking hours)
1. Known severe hypersensitivity to platinum, pemetrexed or any of the excipients of these products or pre-medications.
2. Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) as judged by the investigator
3. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
4. Inadequate organ function.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival <br/ ><br>Timepoint: At the end of study
- Secondary Outcome Measures
Name Time Method PFS <br/ ><br>Toxicities <br/ ><br>QoL <br/ ><br>Optimal Treatment Utility <br/ ><br>Response rate <br/ ><br>Chemotherapy-induced cognitive impairment <br/ ><br>PK PD <br/ ><br>Timepoint: PFS At progression <br/ ><br>Toxicities At every visit <br/ ><br>QOL at baseline and After every 3 cycles, At every follow-up visit, At end of study <br/ ><br>Optimal Treatment Utility after 3rd cycle <br/ ><br>Response rate every 2 months <br/ ><br>Chemotherapy induced cognitive impairment At baseline and every 3 cycle <br/ ><br>PK PD Cycle 1 day 1