Actively Recruiting
A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)
Led by M.D. Anderson Cancer Center · Updated on 2025-11-26
400
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding local consolidation therapy (LCT), such as radiation therapy with or without surgery, ablation, or embolization, to all progressive disease sites can better control oligoprogressive metastatic cancer compared to next-line systemic therapy. This randomized phase II basket trial includes seven tumor types and aims to assess progression-free survival, overall survival, safety, quality of life, and biomarkers predicting benefit from LCT. Participants are randomly assigned to one of two groups. Group 1 receives next-line systemic therapy as determined by their doctor, with the option to switch to LCT if disease progresses. Group 2 receives LCT to progressive sites followed by continued systemic therapy and next-line therapy if needed. The choice of local therapies and radiation regimens is guided by a multidisciplinary team. Treatment plans are personalized based on disease progression and response. During the study, participants undergo imaging scans to identify progressive disease sites, laboratory tests to assess organ function, and evaluations of safety and adverse events over approximately one year. Researchers will monitor progression-free survival, overall survival, and quality of life. Follow-up includes ongoing assessments to track treatment effects and tolerability. Total participation duration and detailed imaging schedules are based on individual disease status and treatment response.
CONDITIONS
Brief Title
A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed stage IV cancer
- ECOG performance status of 2 or less
- Candidate for local consolidation therapy (radiation therapy with or without surgery, ablation, or embolization) to all progressive disease sites
- Progressive disease defined by RECIST (v1.1) criteria with 1 to 5 progressive lesions
- Progressive lesions must be active and amenable to local therapy
- Baseline imaging within 4 weeks prior to randomization including PET/CT or CT chest/abdomen/pelvis; MRI may be substituted if appropriate
- Pre-baseline imaging 6-16 weeks prior to baseline imaging
- Histologic types: colorectal carcinoma, renal cell carcinoma, breast cancer, pancreatic cancer, urothelial (bladder) cancer, prostate cancer, esophageal cancer
- Females of childbearing potential must have negative pregnancy test, not be breastfeeding, and agree to use contraception
- Non-sterilized males sexually active with females of childbearing potential must use contraception
- Adequate organ function as defined by specific laboratory values within 4 weeks prior to enrollment
You will not qualify if you...
- Presence of metastatic effusion (pleural effusion or ascites), except small effusions too small to sample
- Leptomeningeal disease
- Peritoneal carcinomatosis
- Cognitive impairment preventing informed consent
- Any condition interfering with study treatment or results interpretation
- Diffuse bone marrow involvement without radiologic bone metastasis
- More than 4 prior lines of systemic therapy for metastatic disease
- Active scleroderma, lupus, or rheumatologic disease precluding safe radiotherapy
- Known psychiatric or substance abuse disorders interfering with participation
- Concurrent other primary malignancy posing substantial risk as competing cause of death
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants receive either next-line systemic therapy or local consolidation therapy (LCT) to all progressive disease sites, followed by continuation of systemic therapy as determined by their doctor.
Visit schedule depends on assigned treatment and doctor's plan
Duration - Up to study completion
Participants are monitored for safety and adverse events through study completion.
Follow-up visits as scheduled by study team
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Ethan Ludmir, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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