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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 subjects (e.g. inability to sign informed consent.)

Trial design

Design model

Single group

Treatments tested in this trial

  • Local Consolidation Therapy

    Procedure/Surgery

    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/Surgery

    The specific next-line systemic therapy will be determined by your doctor.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: NLST ArmExperimental treatment 1 intervention
Group B: LCT ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and adverse events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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