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

NCT02756793 | Active Not Recruiting DMC

• 1 other identifier: STOP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

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).

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overall Survival

  5 years

• Quality of Life

  5 years

• Toxicity

  5 years

• Lesional Control Rate

  5 years

• Total Time on Chemotherapy

  5 years

Study Arms (2)

Standard of Care Treatment

ACTIVE COMPARATOR

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

Stereotactic Ablative Radiotherapy (SABR)

EXPERIMENTAL

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)

Interventions

Stereotactic Ablative Radiotherapy (SABR) RADIATION

Patients will receive stereotactic ablative radiotherapy to all sites of progressive disease, with continuation of current systemic agents.

Stereotactic Ablative Radiotherapy (SABR)

Standard of Care Treatment OTHER

May include: * Continue with current systemic agent(s) * Observation * Switch to next-line treatment Palliative radiotherapy is allowed in this arm.

Standard of Care Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (7)

Alberta Health Services-Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer - Prince George

Prince George, British Columbia, V2M 7E9, Canada

Location

BC Cancer Fraser Valley Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BC Cancer Agency Branch

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BC Cancer - Victoria Centre

Victoria, British Columbia, V8R 4X1, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G1X6, Canada

Location

Related Publications (2)

• Schellenberg D, Gabos Z, Duimering A, Debenham B, Fairchild A, Huang F, Rowe LS, Severin D, Giuliani ME, Bezjak A, Lok BH, Raman S, Chung P, Zhao Y, Ho CK, Lock M, Louie AV, Lefresne S, Carolan H, Liu M, Yau V, Ye A, Olson RA, Mou B, Mohamed IG, Petrik DW, Dosani M, Pai H, Valev B, Gaede S, Warner A, Palma DA. Stereotactic Ablative Radiation for Oligoprogressive Cancers: Results of the Randomized Phase 2 STOP Trial. Int J Radiat Oncol Biol Phys. 2025 Jan 1;121(1):28-38. doi: 10.1016/j.ijrobp.2024.08.031. Epub 2024 Aug 19.

  PMID: 39168356 DERIVED

• 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.

  PMID: 34903471 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: April 29, 2016
• Study Start: October 1, 2016
• Primary Completion: July 31, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)