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Neoadjuvant chemotherapy in NSCLC

Study of efficacy and safety of neo adjuvant chemotherapy in patients with Stage 2 B and 3 NSCLC: A pilot study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/05/006916
Enrollment
50
Registered
2016-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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 Health Condition 2: null- stage 2b and 3 Non Small Cell Lung Cancer

Interventions

Intervention1: Inj. paclitaxel, Inj. Carboplatin: INJ. Paclitaxel 80 mg/m2 day 1,8,15 Inj. Carboplatin AUC 6 Day 1 Q 3 weekly Control Intervention1: NA: NA Control Intervention2: NA: NA

Sponsors

investigator initiated study
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis of NSCLC 2. Age 18 to 75 years 3. ECOG PS 0-2 4. Local disease T3 (with > 5cm contact with chest wall) or T4 5. Mediastinal stage N0, N1 or non bulky N2 (defined as single station N2 station node

Exclusion criteria

Exclusion criteria: 1. ECOG PS >2 2. Gross mediastinal structures invasion 3. SVCO 4. Immunocompromised 5. Multiple comorbidities precluding possibilty of surgery 6. Poor PFT (predicted post operative FEV1 7. Pregnent and lactating females

Design outcomes

Primary

MeasureTime frame
oRdiological response rates with neoadjuvant chemotherapyTimepoint: At the end of Four cycle of chemotherapy

Secondary

MeasureTime frame
1.Improvement in resectability, (pnemonectomy converted to conservative surgery) 2.Toxicity profile assessment 3.Progression free survival (from date of enrollment till date of disease progression or death ) 4.Post operative/ operarive complications Timepoint: 1. At the end of neoadjuvent chemotherapy. 2. At the end of the therapy.

Countries

India

Contacts

Public ContactPrabhat Singh Malik

Dr.B.R.A.I.R.C.H., All India Institute of Medical Sciences

drprabhatsm@gmail.com01129575232

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 6, 2026