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

NCT04405401 | Recruiting Phase 2 DMC

• 1 other identifier: 2021-9066
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer Metastatic

Keywords

non small cell lung cancer; oligoprogression; steretactic body radiotherapy

Outcome Measures

Primary Outcomes (2)

• PFS

  PFS defined from randomization to disease progression at any site or death

  5 years

• OS

  OS defined as time from randomization to time of death from any cause.

  5 years

Secondary Outcomes (5)

• Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)

  5 years

• Quality of life 5-level EQ-5D (EQ-5D-5L)

  5 years

• Grade ≥ 3 toxicity

  5 years

• Local control

  5 years

• Time to next systemic therapy

  5 years

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Switch to subsequent systemic therapy line, best supportive care or continue current systemic line

Radiation: SABR

Experimental SABR arm

EXPERIMENTAL

Definitive SABR to oligoprogressive lesions + continue current systemic therapy

Other: Standard of care

Interventions

SABR RADIATION

SABR to all oligoprogressive lesions + continuation of current systemic therapy

Standard of care

Standard of care OTHER

Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.

Experimental SABR arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Houda Bahig, MD PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY CHAIR

• Bertrand Routy, MD PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY CHAIR

Central Study Contacts

Silvine Benth

CONTACT

514-890-8254; silvine.benth.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized screening phase II trial

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: May 28, 2020
• Study Start: January 5, 2021
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

CA (1)