A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)

Conditions

• OligoProgressive Metastatic Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Local Consolidation Therapy — PROCEDURE
  Participants may receive radiation therapy. The choice of LCT and radiation therapy regimen will be determined by a multidisciplinary team including the study doctor.
• Next-line Systemic Therapy — PROCEDURE
  The specific next-line systemic therapy will be determined by your doctor.

Study Details

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.

Key Dates

Start date

Jun 6, 2024

Status verified

Jun 2026

Primary completion

Oct 10, 2028

Completion

Oct 10, 2030

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: NLST Arm
  Participants are assigned to Group 1, participants will be treated with next-line systemic therapy. The specific next-line systemic therapy will be determined by your doctor. \- If progression occurs (the disease gets worse), participants may cross over to Group 2 and receive LCT.
• Experimental: LCT Arm
  Participants are assigned to Group 2, participants will be treated with LCT and then continue on same systemic therapy participants have been receiving followed by the next line systemic of therapy (if applicable). The specific treatments will be determined by your doctor.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

• Ethan Ludmir, MD
  (832) 729-0998
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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