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Randomized controlled study comparing between consolidative local radiotherapy and observation after first line systemic treatments for patients with EGFR mutant metastatic non-small cell lung cancers (NSCLC)

Randomized controlled study comparing between consolidative local radiotherapy and observation after first line systemic treatments for patients with EGFR mutant metastatic non-small cell lung cancers (NSCLC)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190904001
Enrollment
56
Registered
2019-09-04
Start date
2019-09-02
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

&#45

Interventions

Controlled arm,Experimental arm Radiation to all sites of residual tumor
Observe,Consolidative Radiation

Sponsors

Ratchadapisek Sompoch
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - 18 years of age or older - An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2 or less. - Lung cancer stage IV disease according to the 8 th edition of the American Joint Committee on Cancer staging system. - Pathologically confirmed NSCLC with EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R mutation) - Had received first-line systemic therapy, either chemotherapy or targeted therapy from King Chulalongkorn Memorial Hospital. - Did not progress during initial first-line systemic treatment. - Synchronous oligometastatic disease (1 to 5 lesions after 4-6 cycles of chemotherapy or 3-4 months of targeted therapy)

Exclusion criteria

Exclusion criteria: &#45; Not meet inclusion criteria. &#45; Patients who needs emergency radiation to the primary tumor or metastatic sites before receiving 1 st line systemic treatment&#44; e.g. symptomatic CNS metastases who are neurologically unstable&#44; spinal cord compression&#44; airway obstruction from tumor. &#45; Patients who have only malignant effusion as a metastatic site after 1 st line systemic treatment. &#45; Females of childbearing or breast feeding. &#45; Pregnancy. &#45; Inadequate bone marrow or organ function as demonstrated by any of the following laboratory values: absolute neutrophil count<1&#44;500/mcl&#44; platelet<100&#44;000/mcl&#44; hemoglobin <8 g/dl. &#45; Complete response to prior systemic treatment to all visible lesions&#44; such that no lesion is amenable to consolidative local radiotherapy.

Design outcomes

Primary

MeasureTime frame
Progression free survival Time to death or progression of disease after randomization Month

Secondary

MeasureTime frame
Overall survival Time to death after randomization Month,Local control Time to local recurrence after randomization Month,Time to new metastasis lesion Time to develop new metastatic lesion after randoimzation Month,Treatment related toxicities During radiation&#44; 1 month&#44; 3 months&#44; 6 months&#44; 1 year after radiation RTOG toxicities grades

Countries

Thailand

Contacts

Public ContactChonnipa Nantavithya

King Chulalongkorn Memorial Hospital

chonnipa.n@chula.ac.th022564334

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026