Clinical Trials /

Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer

NCT04405401

Description:

A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer
  • Official Title: Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial

Clinical Trial IDs

  • ORG STUDY ID: PERaLung2.0
  • NCT ID: NCT04405401

Conditions

  • Lung Cancer Metastatic

Purpose

A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

Trial Arms

NameTypeDescriptionInterventions
Standard of careActive ComparatorSwitch to subsequent systemic therapy line, best supportive care or continue current systemic line
    Experimental SABR armExperimentalDefinitive SABR to oligoprogressive lesions + continue current systemic therapy

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Age ≥18 years
      
                -  Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the
                   PERa registry
      
                -  Ability to provide written informed consent
      
                -  Eastern Cooperative Oncology Group (ECOG) performance status 0-3
      
                -  Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs.
                   Progression at the primary tumor site should be counted within the total of 5 lesions.
                   For patients with lymph node metastases, each node is counted as one site of
                   metastasis.
      
                -  Oligoprogression while on ICI or TKI (any line)
      
                -  Patients with brain metastasis are allowed; brain metastasis are not counted in the
                   maximum number of lesions and should be treated as per standard of care
      
                -  All sites of disease can, in the opinion of the investigator, be safely treated and
                   targetable with SABR (taking into account prior local therapy, organ function and
                   underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis,
                   etc.)
      
                -  Patients with prior metastases that have been treated with ablative therapies (e.g.
                   radiotherapy, surgery or radiofrequency ablation) before their current line of
                   systemic therapy, are eligible.
      
              Exclusion Criteria:
      
                -  Any lesion beyond 5 cm
      
                -  Pregnancy or breastfeeding
      
                -  Any medical condition that could, in the opinion of the investigator, preclude
                   radiotherapy or prevent follow-up after radiotherapy.
      
                -  Presence of spinal cord compression Metastatic disease that invades the GI tract
                   (including esophagus, stomach, small or large bowel)
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:PFS
      Time Frame:5 years
      Safety Issue:
      Description:PFS defined from randomization to disease progression at any site or death

      Secondary Outcome Measures

      Measure:Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)
      Time Frame:5 years
      Safety Issue:
      Description:Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)
      Measure:Quality of life 5-level EQ-5D (EQ-5D-5L)
      Time Frame:5 years
      Safety Issue:
      Description:questionnaire
      Measure:Grade ≥ 3 toxicity
      Time Frame:5 years
      Safety Issue:
      Description:Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
      Measure:Local control
      Time Frame:5 years
      Safety Issue:
      Description:Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm
      Measure:Time to next systemic therapy
      Time Frame:5 years
      Safety Issue:
      Description:Defined as time from randomization to time of subsequent therapy line

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:Centre hospitalier de l'Université de Montréal (CHUM)

      Trial Keywords

      • non small cell lung cancer
      • oligoprogression
      • steretactic body radiotherapy

      Last Updated

      May 31, 2020