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

• ClinicalTrials.gov Identifier: NCT02756793
• Recruitment Status: Active, not recruiting
• First Posted: April 29, 2016
• Last Update Posted: August 24, 2022
• Sponsor: Lawson Health Research Institute
• Information provided by (Responsible Party): David Palma, Lawson Health Research Institute

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).

Condition or disease	Intervention/treatment	Phase
Metastatic Cancer	Radiation: Stereotactic Ablative Radiotherapy (SABR); Other: Standard of Care Treatment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial): A Randomized Phase II Trial
• Study Start Date: October 2016
• Actual Primary Completion Date: July 31, 2022
• Estimated Study Completion Date: June 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Standard of Care Treatment; 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	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.
Experimental: 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.	Radiation: Stereotactic Ablative Radiotherapy (SABR); Patients will receive stereotactic ablative radiotherapy to all sites of progressive disease, with continuation of current systemic agents.

Outcome Measures

Primary Outcome Measures :

1. Progression-Free Survival [ Time Frame: 5 years ]
   Progression-Free Survival is defined as the time from randomization to progression of disease or death from any cause

Secondary Outcome Measures :

1. Overall Survival [ Time Frame: 5 years ]
   Overall survival is defined as they time from randomization to death from any cause
2. Quality of Life [ Time Frame: 5 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)
3. Toxicity [ Time Frame: 5 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)
4. Lesional Control Rate [ Time Frame: 5 years ]
   Local control rate of lesions treated with SABR
5. Total Time on Chemotherapy [ Time Frame: 5 years ]
   Duration of systemic therapy treatment
6. Duration of current systemic agent treatment after SABR [ Time Frame: 5 years ]
   Arm 2 only
7. Location of sites of further progression after SABR [ Time Frame: 5 years ]
   Sites of progressive disease after SABR are captured in follow up

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Alberta

Alberta Health Services-Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, British Columbia

BC Cancer - Prince George

Prince George, British Columbia, Canada, V2M 7E9

BC Cancer Fraser Valley Centre

Surrey, British Columbia, Canada, V3V 1Z2

BC Cancer Agency Branch

Vancouver, British Columbia, Canada, V5Z 4E6

BC Cancer - Victoria Centre

Victoria, British Columbia, Canada, V8R 4X1

Canada, Ontario

London Regional Cancer Program

London, Ontario, Canada, N6A 4L6

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G1X6

Sponsors and Collaborators

Lawson Health Research Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: David Palma, Principal Investigator, Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT02756793
• Other Study ID Numbers: STOP
• First Posted: April 29, 2016
• Last Update Posted: August 24, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Neoplasm Metastasis; Neoplasms; Neoplasms, Second Primary; Neoplastic Processes; Pathologic Processes