Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial)

Metastatic Cancer Clinical Trial

Official title:

Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial): A Randomized Phase II Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02756793
• Other study ID #: STOP
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: June 2026

Study information

• Verified date: September 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter randomized phase II trial of stereotactic body radiotherapy for oligo-progressive metastatic cancers. Eligible patients will be randomized in a 1:2 ratio between receiving their standard of care therapy or stereotactic ablative radiotherapy (SABR) to all sites of oligo-progressive lesions.Radiotherapy will be administered as soon as possible following randomization, and subjects will be followed until next disease progression. The primary outcome is progression-free survival (PFS).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 2026
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older
• Willing to provide informed consent
• Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) with metastatic disease detected on imaging. Biopsy of metastasis at some time point prior to enrollment is preferred, but not required.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy > 3 months
• Patient has received treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies) during the past 6 weeks. This most recent systemic therapy agent must have been delivered for a total of at least 3 months, with an initial partial response (PR), complete response (CR) or stable disease (CR) prior to the development of oligo-progressive lesions.
• Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST)-documented progression in up to 5 individual lesions, with no previous radiation or radiofrequency ablation to those sites. Oligoprogression may be defined

as:

• Progression of an individual metastasis according to RECIST 1.1 criteria
• Unambiguous development of a new metastatic lesion at least 5mm in size
• Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2- 3 months apart with a minimum 5mm increase in size from baseline
• All sites of oligoprogression can be safely treated
• Maximum 3 progressing metastases in any single organ system (i.e. lung, liver, brain, bone), and the total number of metastases must be 5 or less Note for Patients with Brain Metastases: For patients with brain metastases and oligo-progression elsewhere where stereotactic radiation to the brain is deemed to be warranted, this must be specified prior to randomization. If randomized to Standard Arm, patient would receive stereotactic radiation to brain only. If randomized to Experimental Arm, patient would receive stereotactic radiation to brain and to body lesions

Exclusion Criteria:

• Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma. For patients with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease
• Prior radiotherapy to a site requiring treatment
• Malignant pleural effusion
• Inability to treat all sites of enlarging, oligoprogressive disease
• Clinical or radiological evidence of spinal cord compression or tumor within 3mm of spinal cord on MRI
• Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

Radiation:
• Stereotactic Ablative Radiotherapy (SABR)
Patients will receive stereotactic ablative radiotherapy to all sites of progressive disease, with continuation of current systemic agents.

Other:
• Standard of Care Treatment
May include: Continue with current systemic agent(s) Observation Switch to next-line treatment Palliative radiotherapy is allowed in this arm.

Locations

Country	Name	City	State
Canada	Alberta Health Services-Cross Cancer Institute	Edmonton	Alberta
Canada	London Regional Cancer Program	London	Ontario
Canada	BC Cancer - Prince George	Prince George	British Columbia
Canada	BC Cancer Fraser Valley Centre	Surrey	British Columbia
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	BC Cancer Agency Branch	Vancouver	British Columbia
Canada	BC Cancer - Victoria Centre	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	Progression-Free Survival is defined as the time from randomization to progression of disease or death from any cause	5 years
Secondary	Overall Survival	Overall survival is defined as they time from randomization to death from any cause	5 years
Secondary	Quality of Life	Quality of life in domains of physical, social/family, emotional, and functional well-being will be assessed with the Functional Assessment of Cancer Therapy (FACT-G)	5 years
Secondary	Toxicity	Toxicity related to radiation treatment will be assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (i.e. liver, lung, bone)	5 years
Secondary	Lesional Control Rate	Local control rate of lesions treated with SABR	5 years
Secondary	Total Time on Chemotherapy	Duration of systemic therapy treatment	5 years
Secondary	Duration of current systemic agent treatment after SABR	Arm 2 only	5 years
Secondary	Location of sites of further progression after SABR	Sites of progressive disease after SABR are captured in follow up	5 years