SBRT in Multi-metastatic NSCLC Patients Which Are Pan-negative for Driver Mutations

Sponsor
Shanghai Chest Hospital
Study ID
NCT02940990
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This protocol is a phase II multi-center randomized controlled trial (RCT) evaluating the efficacy of SBRT in multi-metastatic NSCLC patients who are pan-negative for driver mutations.

Key Dates

Start date
Nov 30, 2016
Status verified
Nov 2016
Primary completion
Dec 31, 2019

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Group A
    Participants in the Group A will receive 4-6 cycles of standard two-drug chemotherapy. After that, clinical observation or maintenance chemotherapy will be given.
  • Experimental: Group B
    Participants in the Group B will also receive 4-6 cycles of standard two-drug chemotherapy. However, they will receive an additional treatment of SBRT to primary lesions or metastatic lesions combined with GM-CSF.

Primary Outcome Measure

Progress Free Survival (PFS) [ Time Frame: 2 years ]

Related Studies