Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor

  • STATUS
    Recruiting
  • participants needed
    367
  • sponsor
    M.D. Anderson Cancer Center
Updated on 5 February 2023

Summary

This phase II trial studies how well systemic therapy with or without local consolidative therapy work in treating patients with solid tumor that has spread to 1 site of other places in the body. Treatment with up-front local consolidative therapy may be better in helping to control the disease.

Description

PRIMARY OBJECTIVES:

I. In patients with oligometastatic malignancies, to assess progression free survival (PFS) with upfront local consolidative therapy (LCT) versus (vs.) no LCT among randomized patients.

SECONDARY OBJECTIVES:

I. In patients with oligometastatic malignancies, to assess overall survival (OS) with upfront LCT vs. no LCT among randomized patients.

II. In patients with oligometastatic malignancies, to assess time to next line systemic therapy with upfront LCT vs. no LCT.

III. In patients with oligometastatic malignancies, to assess time to new lesion failure with upfront LCT vs. no LCT.

IV. To assess safety/tolerability of upfront LCT in patients with oligometastatic malignancies.

V. In patients with oligometastatic malignancies, to assess quality of life with upfront LCT vs. no LCT.

EXPLORATORY OBJECTIVES:

I. To identify predictive/prognostic biomarkers that are associated with a benefit to LCT across disease sites.

II. To investigate the systemic immune activating effects of radiation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive up-front standard of care LCT including but not limited to surgical resection, cryotherapy, and radiofrequency ablation. Patients then receive routine drug therapy.

ARM II: Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor.

After completion of study, patients are followed up every 18 weeks.

Details
Condition Oligometastatic Malignant Solid Neoplasm
Treatment Best Practice, Local Consolidation Therapy
Clinical Study IdentifierNCT03599765
SponsorM.D. Anderson Cancer Center
Last Modified on5 February 2023

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note