ocal Ablative therapy for Oligometastases NSCLC - An Ambispective Observational Cohort Study

Not Applicable

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

• Registration Number: CTRI/2022/05/042654
• Lead Sponsor: Anil Tibdewal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Patients with histopathological diagnosis of non-small cell lung cancer

2)Patients with age > 18 years

3)Patients with confirmed oligoprogression in <=3 intracranial and extracranial sites of disease (excluding primary and regional nodal sites) - All sites must be visible, imaging defined targets, not previously treated with radical radiation or radiofrequency and suitable for treatment with LAT as determined by the radiation oncologist).

4)Patients with oligoprogression in <=5 intracranial disease sites with no extracranial sites of progression. All sites must be visible, imaging defined targets, previous treatment of current sites with WBRT/SRS is acceptable with duration between treatment and OP is at-least 6 months.

5)Patients with oligorecurrent disease at primary and/or regional nodal sites (previously covered in RT portal is allowed if can be treated radically again) with or without distant metastases in previously treated non-metastatic NSCLC.

6)Patients with metastatic NSCLC with all sites responding to systemic therapy (TKI/Chemotherapy/ICI) except few (1-3) â?? Oligopersistent diseases

7)Patient with completely resolved or stable pleural effusion is allowed but with no new onset malignant pleural or pericardial effusion

8)All sites must be amenable either by local ablative radiation therapy (with SBRT/ Radical RT - conventional or hypofractionated RT) or RFA or Surgery

9)At least one site should be treated with radiation therapy. Only RFA or Only Surgically treated patients will be excluded except patients with post-operative whole brain radiation therapy with or without boost or post-operative cavity stereotactic radiosurgery.

10)Adequate baseline organ function to allow LAT to all the OP, OR or Oligopersistent targets.

11)Karnofsky Performance status >= 60 and ECOG 0-2 (except patients with brain metastases where PS is declined solely due to brain s)

12)Provision of written informed consent

Exclusion Criteria

1)Age < 18 years

2) > 3 sites of oligoprogressive disease (except mentioned for intracranial sites only)

3)OP, OR and oligopersistence disease not amenable to LAT

4)Co-morbidities considered clinically precluding the safe use of LAT

5)Any psychological, sociological or geographical issue potentially hampering compliance with the study

6)Pregnancy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the progression free survival defined as the time from initiation of local ablative therapy till the date of second progression or death whichever is earlierTimepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
Time to change of systemic therapy (time from LAT until initiation of next line systemic therapy or death)Timepoint: 12 months;Time to development of new sites of metastasesTimepoint: 12 months