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

Locally Ablative Therapy for Oligo-Progressive, Oligo-Recurrent and Oligo-Persistent Non-Small Cell Lung Cancer â?? An Ambispective Observational Cohort study (OLIGO-CHROME)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/05/042654
Enrollment
300
Registered
2022-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Interventions

Intervention1: NIL: NIL

Sponsors

Anil Tibdewal
Lead Sponsor

Eligibility

Inclusion criteria

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 4)Patients with oligoprogression in 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

Exclusion criteria: 1)Age 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 metastases Timepoint: 12 months

Countries

India

Contacts

Public ContactAnil Tibdewal

Tata Memorial Hospital

aniltibdewal@gmail.com02224177030

Outcome results

None listed

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