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Study to do comparison of Quality life questionnaire of lung cancer patients receiving chemotherapy ( Pemetrexed versus Erlotinib)

Comparative study of QOL of patients on Pemetrexed versus Erlotinib in Maintenance therapy for Advanced NSCLC (Other than Squamous Cell Carcinoma)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/08/004847
Enrollment
200
Registered
2014-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Advanced Carcinoma Lung Patients taking either pemetrexed or Erlotinib.

Interventions

Intervention1: Nil: nil Control Intervention1: Pemetrexed: The patients will be receiving Pemetrexed as maintenance therapy of Non-squamous NSCLC Control Intervention2: Erlotinib: The patients will

Sponsors

Tata Memorial Hospital
Lead Sponsor
Not yet available
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. TKI-naive patients with documented Stage III OR Stage IV NSCLC who experience stable disease/ partial response/ complete response after 4-6 cycles of Pemetrexed + Cisplatin/Carboplatin chemotherapy. 2. ECOG Performance status (PS) from 0 to 2 3. Age >= 18yrs 4. Adequate bone marrowtests (absolute neutrophil count >1500/lL, hemoglobin > 8 g/dL, and platelet count >100,000/lL), renalfunction tests (creatinine 5. Life expectancy >= 3 months 6. Clinically stablebrain metastases if any

Exclusion criteria

Exclusion criteria: 1. Prior therapy with TKI 2. Squamous cell Histology 3. A second primary tumor 4. Uncontrolled infection 5. Uncontrolled co-morbidities Premenopausal women will be required to practice a suitable method of birth control and have a negative pregnancy test.

Design outcomes

Secondary

MeasureTime frame
1. Safety and Toxicity of these two regimens 2. PFS and OS in these two regimens Timepoint: Safety & toxicity at every Follow Up visit PFS & OS at every regular F/U

Primary

MeasureTime frame
Study the QOL in these two regimes at 3 monthsTimepoint: At every 3 months

Countries

India

Contacts

Public ContactDr Kumar Prabhash

Tata Memorial Hospital

drvivekagarwala@gmail.com08879222875

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 24, 2026