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Compares treatment options for Oligoprogression
Official title Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers
ClinicalTrials.gov ID: NCT06918951
What this study is testing
- What it's testing
- STOP-2 is a phase III multi-institutional double-blind randomized trial. 194 participants will be enrolled in this trial.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Age 19 or older
- Able to provide informed consent
- Histologically confirmed solid malignancy (excluding lymphoma or myeloma) with metastatic disease detected on imaging
- Biopsy of metastasis at some time prior to enrollment is preferred, but not required
- ECOG performance status 0-2
You likely can't join if
- Serious medical comorbidities precluding radiotherapy. These include ataxia-telangiectasia or scleroderma, Crohn's disease in participants where the...
- Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, provided that the composite plan meets dose...
- Current malignant pleural effusion, malignant ascites, or leptomeningeal disease
- Inability to treat all sites of oligoprogressive disease
- Liver metastases requiring placement of fiducial markers for SABR, as this would compromise successful blinding. Liver metastases are eligible if: 1)...
- Brain metastasis \> 3.5 cm in size or a total volume of brain metastases greater than 30 cc.
See the full eligibility criteria
- Age 19 or older
- Able to provide informed consent
- Histologically confirmed solid malignancy (excluding lymphoma or myeloma) with metastatic disease detected on imaging
- Biopsy of metastasis at some time prior to enrollment is preferred, but not required
- ECOG performance status 0-2
- Life expectancy ≥ 6 months
- Progression meeting RECIST criteria in up to 5 individual lesions. Progression may be defined as:
- Progression of an individual metastasis according to RECIST 1.1 criteria (≥ 20% enlargement of the tumour vs. baseline or nadir, taking as reference the smallest diameter seen prior to starting or during systemic...
- Unambiguous development of a new metastatic lesion at least 5 mm in size OR
- Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2-3 months apart with a minimum 5 mm increase in size from baseline.
- A progressing primary tumor is eligible as per the criteria above
- If the participant is on systemic therapy at the time of oligoprogression: The most recent systemic therapy agent must have been delivered for a total of at least 3 months, with an initial partial response (PR)...
- If the participant is not on systemic therapy at the time of oligoprogression: (i.e., "oligorecurrence"(1), however, included as "oligoprogression" for the purpose of this study protocol):
- There must be PR, CR or SD persisting for at least 3 months prior to the development of oligoprogressive lesions
- Participants who are not on systemic therapy at the time of oligoprogression must have other site(s) of disease (metastases or primary tumor) that are stable or resolved and have not received definitive treatment...
- All sites of oligoprogression can be safely treated
- Restaging completed within 12 weeks prior to randomization (see section 5.1)
- Negative urine pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of radiotherapy start date.
- Serious medical comorbidities precluding radiotherapy. These include ataxia-telangiectasia or scleroderma, Crohn's disease in participants where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative...
- Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, provided that the composite plan meets dose constraints herein. For participants treated with radiation...
- Current malignant pleural effusion, malignant ascites, or leptomeningeal disease
- Inability to treat all sites of oligoprogressive disease
- Liver metastases requiring placement of fiducial markers for SABR, as this would compromise successful blinding. Liver metastases are eligible if: 1) they are treated at an institution that offers liver SABR without...
- Brain metastasis \> 3.5 cm in size or a total volume of brain metastases greater than 30 cc.
- Clinical or radiologic evidence of spinal cord compression. Participants can be eligible if surgical resection has been performed.
- Participants with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of \>12.
- Dominant brain metastasis requiring surgical decompression
- For participants with liver metastases; moderate/severe liver dysfunction (Child Pugh B or C)
- Liver metastases located in the "Biliary no fly zone" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm
- Surgical resection of all oligoprogression metastases (i.e. no lesion available to be treated with SABR)
- Pregnant or lactating individuals
The study team makes the final eligibility decision.
Where it's taking place
- Surrey, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Surrey, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.