Study to evaluate the role of Pirfenidone in preventing radiation induced lung damage

Prophylactic pirfenidone for prevention of radiation induced pneumonitis in patients with Lung cancer (PROPER study) - PROPER

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/035223

Enrollment

Registered

2021-07-28

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: C348- Malignant neoplasm of overlappingsites of bronchus and lung

Interventions

Intervention1: Pirfenidone: Pirfenidone [PFD

5-methyl-1-phenyl-2(1H)-pyridone] is an orally-administered, synthetic pyridone compound, which is approved for the treatment of idiopathic pulmonary fibrosis in the European Union, U.S. and Japan. Se

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. 18-70 years old, male or female 2. General condition assessment, ECOG score of 0-1 3. Pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) 4. Candidate for radical treatment with radiation therapy with or without chemotherapy 5. Expected survival at 6 months or more

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Unable to perform or any contra-indications for performing PFT 2. Concurrent / active pulmonary infection 3. Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc. 4. Chronic liver disease/cirrhosis 5. With active peptic ulcer 6. Unwilling to take radiation therapy at TMH 7. Pregnant women and patients with known psychiatric/psychological disorders

Design outcomes

Primary

Measure	Time frame
To study the role of PFD in reducing the decline of pulmonary function tests (FEV1/DLco/6-minute walk test) at 3-months post radiation compared to pre-RT valuesTimepoint: Three months post radiation therapy	—

Secondary

Measure	Time frame
Secondary objective 1. To study the evolution of radiological features of pneumonitis in patients receiving thoracic radiation and oral pirfenidone. 2. Progression free survival 3. Overall survival 4. Quality of life as measured by QOL questionnaires (EORTC QLQ C-30, QLQ LC-13)Timepoint: Three months post radiation therapy	—

Countries

India

Contacts

Public ContactNaveen Mummudi

Tata Memorial Hospital, Mumbai

mbnaveenkb@gmail.com7045304006

Outcome results

None listed

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