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Tests treatment safety and results for OligoProgressive Metastatic Disease
Official title A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)
ClinicalTrials.gov ID: NCT06367972
What this study is testing
- What it's testing
- To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation [the removal or destruction of a body part or tissue or its function], or embolization [a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy.
- Phase 3: a large, late-stage study
- 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 18 and older
You may be able to join if
- Age ≥18
- Histologically or cytologically confirmed stage IV cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Candidate for LCT (radiation therapy +/- other local therapies such as surgery, ablation, or embolization) to all sites of progressive disease.
- Progressive disease will be defined as a discrete radiologic lesion that has not received prior local therapy. Progressive disease will be defined as...
You likely can't join if
- Metastatic effusion (e.g. pleural effusion or ascites). Note that participants with an effusion that is too small to sample will be eligible for the...
- Leptomeningeal disease.
- Peritoneal carcinomatosis.
- Cognitively impaired people (e.g. inability to sign informed consent.)
- Any condition that, in the opinion of the investigator, would interfere with the study treatment or interpretation of the study results.
- Diffuse bone marrow involvement as defined by disease involvement of a BM biopsy from a site that does not have radiologic evidence of a bone...
See the full eligibility criteria
Who can join
- Age ≥18
- Histologically or cytologically confirmed stage IV cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Candidate for LCT (radiation therapy +/- other local therapies such as surgery, ablation, or embolization) to all sites of progressive disease.
- Progressive disease will be defined as a discrete radiologic lesion that has not received prior local therapy. Progressive disease will be defined as RECIST (v1.1) defined progression from pre-baseline imaging to...
- Progressive disease must represent an active lesion, which may be defined as the primary tumor site, regional nodal disease, and/or distant metastatic sites.
- Candidate for radiation therapy to at least one site of disease.
- Between one and five progressive lesions, counted as follows: each lesion (not site) will be counted as one, with the exception of metastatic lymph node stations, which will collectively count as one lesion. Regional...
- Counting of oligoprogressive nodal disease will be based on nodal chains. A nodal chain will be considered a single metastatic lesion if the presence of that node results in the patient as having M1 disease per the TNM...
- In participants with a LN exhibiting a short axis ≥15mm and who have other diagnoses that can produce enlarged LNs (e.g. indolent CLL, sarcoidosis, etc…) or a prior history of benign enlarged LNs will not be considered...
- LN chains that occur bilaterally will be considered separate metastatic sites. For example, left axilla LNs will counted separately from right axilla LNs.
- The following midline LN chains will be counted as 1 metastatic site: mediastinal, para-aortic, mesenteric.
- The following bilateral LN chains will be counted as 1 metastatic site for unilateral involvement, and 2 for bilateral for involvement: preauricular, cervical and occipital, supraclavicular, infraclavicular, pectoral...
- Baseline imaging must include a scan done within 4 weeks prior to randomization, demonstrating oligoprogressive disease by RECIST (v1.1) criteria compared to pre-baseline imaging.
- Baseline imaging must be done within 4 weeks prior to randomization, and the following imaging is required: PET/CT scan or CT scan of the chest/abdomen/pelvis. MRI may be substituted as indicated (i.e., CT scan of chest...
- Pre-baseline imaging must be done 6-16 weeks prior to baseline imaging, and it is recommended to have a comparable imaging modality (matched modalities between pre-baseline and baseline imaging). RECIST v1.1 will be...
- Participants referred for the study that require immediate LCT can receive treatment to CNS lesions or other symptomatic lesions prior to randomization, but these lesions will be counted towards the total number of...
- Has one of the following 7 histologic types (metastatic disease): colorectal carcinoma (CRC), renal cell carcinoma (RCC), breast cancer, pancreatic cancer, urothelial (bladder) cancer, prostate cancer, and esophageal...
- Females of childbearing potential must not be breast feeding and must have a negative serum or urine pregnancy test and must agree to use adequate contraception from the time of screening until 3 months after...
- Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and 3 month after the last dose of study medication. Adequate...
- Demonstration of adequate organ function as defined in the table below, all screening labs to be performed within 4 weeks prior to study enrollment:
- Table of Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) = ≥500 /mcL Platelets = ≥25,000 / mcL Hemoglobin = ≥7 g/dL Hepatic Serum total bilirubin = ≤ 1.5...
What rules you out
- Metastatic effusion (e.g. pleural effusion or ascites). Note that participants with an effusion that is too small to sample will be eligible for the trial.
- Leptomeningeal disease.
- Peritoneal carcinomatosis.
- Cognitively impaired people (e.g. inability to sign informed consent.)
- Any condition that, in the opinion of the investigator, would interfere with the study treatment or interpretation of the study results.
- Diffuse bone marrow involvement as defined by disease involvement of a BM biopsy from a site that does not have radiologic evidence of a bone metastasis.
- More than 4 prior lines of systemic therapy to treat metastatic disease.
- Diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe delivery of radiotherapy.
- Known psychiatric or substance abuse disorder/s that would interfere with trial participation.
- Concurrent (synchronous or metachronous) other primary malignancy that in the opinion of the treating physician team presents a substantial risk to the participant's life as a competing risk of death (against the...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.