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

Not Applicable
Active, not recruiting
Conditions
Metastatic Cancer
Interventions
Radiation: Stereotactic Ablative Radiotherapy (SABR)
Other: Standard of Care Treatment
Registration Number
NCT02756793
Lead Sponsor
Lawson Health Research Institute
Brief 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).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
90
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

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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Stereotactic Ablative Radiotherapy (SABR)Stereotactic Ablative Radiotherapy (SABR)SABR is delivered to all sites of progressive disease with continuation of current systemic agents. Further oligo-progressive lesions may be treated with SABR if possible. Upon progression at sites not amenable to SABR, the patient may receive any of the options in Arm 1.
Standard of Care TreatmentStandard of Care TreatmentPatient treatment may include the following 3 options, at the discretion of the treating physicians: * Continue with current systemic agent(s) * Observation * Switch to next-line treatment
Primary Outcome Measures
NameTimeMethod
Progression-Free Survival5 years

Progression-Free Survival is defined as the time from randomization to progression of disease or death from any cause

Secondary Outcome Measures
NameTimeMethod
Overall Survival5 years

Overall survival is defined as they time from randomization to death from any cause

Quality of Life5 years

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)

Location of sites of further progression after SABR5 years

Sites of progressive disease after SABR are captured in follow up

Total Time on Chemotherapy5 years

Duration of systemic therapy treatment

Duration of current systemic agent treatment after SABR5 years

Arm 2 only

Toxicity5 years

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)

Lesional Control Rate5 years

Local control rate of lesions treated with SABR

Trial Locations

Locations (7)

BC Cancer Agency Branch

🇨🇦

Vancouver, British Columbia, Canada

Alberta Health Services-Cross Cancer Institute

🇨🇦

Edmonton, Alberta, Canada

BC Cancer - Prince George

🇨🇦

Prince George, British Columbia, Canada

BC Cancer Fraser Valley Centre

🇨🇦

Surrey, British Columbia, Canada

BC Cancer - Victoria Centre

🇨🇦

Victoria, British Columbia, Canada

Princess Margaret Cancer Centre

🇨🇦

Toronto, Ontario, Canada

London Regional Cancer Program

🇨🇦

London, Ontario, Canada

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