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Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC

ConditionsOligometastatic DiseaseMetastatic Non Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTata Memorial Hospital

About this trial

Standard Maintenance Therapy versus Local Consolidative Radiation Therapy and standard maintenance therapy in 1-5 sites of OligoMetastatic Non-small cell lung cancer (NSCLC): A Phase III Randomized Controlled Trial

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Patients with ECOG performance status of 0-2

Patients with pathologically proven diagnosis of NSCLC

Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than or equal to 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)

Disqualifiers

Patients with progressive disease after initial standard systemic therapy

Patients with oncogene driver mutations

Patients with more than 5 sites of oligo metastases

Patients with metastatic lesion size of more than 5 cm

Trial design

Design model

Parallel

Treatments tested in this trial

  • Local consolidative radiation therapy

    Radiation

    Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site

  • Standard maintenance therapy as decided by the treating medical oncologist

    Drug

    Standard maintenance therapy/Observation

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: ARM A: Standard maintenance therapy aloneActive comparator 1 intervention
Group B: ARM B: Local consolidative radiation therapy (LCRT)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Overall survival is defined as the duration between the date of randomization to the date of death due to any cause or the date of last follow-up, whichever is earlier.

Time frame
Upto 2 years

Secondary outcomes

1

Progression free survival (PFS )

Progression free survival is defined as the duration between the date of randomization to the date of first documented progression or death due to any cause or date of last follow-up, whichever is earlier.

Time frame
Upto 2 years
2

Local control rates of treated sites

Local control rate will be defined as the absence of progressive disease at the treated sites

Time frame
Upto 2 years
3

New distant metastases

Time to onset of new distant metastases

Time frame
Upto 2 years
4

Health Related QOL using the EORTC-QLQ-C30 questionnaire

To evaluate patient reported outcomes between the two arms

Time frame
From randomization every 3 months till 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov
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