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

Primary Purpose

Metastatic Cancer

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Ablative Radiotherapy (SABR)
Standard of Care Treatment
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Health Services-Cross Cancer Institute
  • BC Cancer - Prince George
  • BC Cancer Fraser Valley Centre
  • BC Cancer Agency Branch
  • BC Cancer - Victoria Centre
  • London Regional Cancer Program
  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care Treatment

Stereotactic Ablative Radiotherapy (SABR)

Arm Description

Patient 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival
Overall survival is defined as they time from randomization to death from any cause
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)
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)
Lesional Control Rate
Local control rate of lesions treated with SABR
Total Time on Chemotherapy
Duration of systemic therapy treatment
Duration of current systemic agent treatment after SABR
Arm 2 only
Location of sites of further progression after SABR
Sites of progressive disease after SABR are captured in follow up

Full Information

First Posted
April 28, 2016
Last Updated
September 30, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02756793
Brief Title
Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial)
Official Title
Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial): A Randomized Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Treatment
Arm Type
Active Comparator
Arm Description
Patient 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
Arm Title
Stereotactic Ablative Radiotherapy (SABR)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Ablative Radiotherapy (SABR)
Intervention Description
Patients will receive stereotactic ablative radiotherapy to all sites of progressive disease, with continuation of current systemic agents.
Intervention Type
Other
Intervention Name(s)
Standard of Care Treatment
Intervention Description
May include: Continue with current systemic agent(s) Observation Switch to next-line treatment Palliative radiotherapy is allowed in this arm.
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
Progression-Free Survival is defined as the time from randomization to progression of disease or death from any cause
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is defined as they time from randomization to death from any cause
Time Frame
5 years
Title
Quality of Life
Description
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)
Time Frame
5 years
Title
Toxicity
Description
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)
Time Frame
5 years
Title
Lesional Control Rate
Description
Local control rate of lesions treated with SABR
Time Frame
5 years
Title
Total Time on Chemotherapy
Description
Duration of systemic therapy treatment
Time Frame
5 years
Title
Duration of current systemic agent treatment after SABR
Description
Arm 2 only
Time Frame
5 years
Title
Location of sites of further progression after SABR
Description
Sites of progressive disease after SABR are captured in follow up
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alberta Health Services-Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer - Prince George
City
Prince George
State/Province
British Columbia
ZIP/Postal Code
V2M 7E9
Country
Canada
Facility Name
BC Cancer Fraser Valley Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
BC Cancer Agency Branch
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
BC Cancer - Victoria Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4X1
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34903471
Citation
Lee J, Koom WS, Byun HK, Yang G, Kim MS, Park EJ, Ahn JB, Beom SH, Kim HS, Shin SJ, Kim K, Chang JS. Metastasis-Directed Radiotherapy for Oligoprogressive or Oligopersistent Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2022 Jun;21(2):e78-e86. doi: 10.1016/j.clcc.2021.10.009. Epub 2021 Nov 18.
Results Reference
derived

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

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