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
331 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Candidate for local consolidation therapy (radiation therapy with or without surgery, ablation, or embolization) to all progressive disease sites
- Progressive disease defined as new or growing lesions not previously treated locally according to RECIST v1.1 criteria
- Progressive lesions may include primary tumor, regional lymph nodes, or distant metastases
- Candidate for radiation therapy to at least one disease site
- Between one and five progressive lesions, with specific counting rules for lymph node chains
- Baseline imaging within 4 weeks before randomization including PET/CT or CT of chest/abdomen/pelvis, MRI if indicated
- Pre-baseline imaging 6-16 weeks before baseline imaging with comparable imaging modality recommended
- Immediate local therapy to symptomatic or CNS lesions allowed before randomization and counted in lesion total
- Diagnosed with one of seven histologic types: colorectal carcinoma, renal cell carcinoma, breast cancer, pancreatic cancer, urothelial (bladder) cancer, prostate cancer, or esophageal cancer
- Females of childbearing potential must have negative pregnancy test, not be breastfeeding, and agree to use adequate contraception during and 3 months after study
- Non-sterilized sexually active males must use adequate contraception during and 3 months after study and avoid sperm donation during this time
- Adequate organ function demonstrated by laboratory tests within 4 weeks prior to enrollment
You will not qualify if you...
- Presence of metastatic effusion such as pleural effusion or ascites (small effusions too small to sample allowed)
- Leptomeningeal disease
- Peritoneal carcinomatosis
- Cognitive impairment preventing informed consent
- Any condition interfering with study treatment or result interpretation as judged by investigator
- Diffuse bone marrow involvement without radiologic bone metastasis
- More than four prior systemic therapy lines for metastatic disease
- Active scleroderma, lupus, or rheumatologic disease precluding safe radiotherapy
- Known psychiatric or substance abuse disorders interfering with participation
- Concurrent other primary cancer posing substantial life risk competing with study cancer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Ethan Ludmir, MD
CONTACT
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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