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

Program Status

Active, not recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

For Participants With Oligometastatic Solid Tumor
(=< 5 metastatic lesions at the time of study entry)

Participants are randomized to 1 of 2 arms.

ARM I: Participants receive up-front standard of care local consolidative therapy (LCT), including but not limited to surgical resection, cryotherapy, and radiofrequency ablation. Participants then receive routine drug therapy/ standard of care (SOC) .

ARM II: Participants receive routine drug therapy/ standard of care (SOC) . Participants may later receive LCT at the discretion of doctor.

Location Location Status
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Active, not recruiting
Baptist Health Medical Center
Little Rock, Arkansas 72205
Active, not recruiting
Queen's Medical Center
Honolulu, Hawaii 96813
Active, not recruiting
Community Health Center
Coldwater, Michigan 49036
Active, not recruiting
Cooper Hospital University Medical Center
Camden, New Jersey 08103
Active, not recruiting
OhioHealth Mansfield Hospital
Mansfield, Ohio 44903
Active, not recruiting
M D Anderson Cancer Center
Houston, Texas 77030
Active, not recruiting
MD Anderson in Katy
Houston, Texas 77094
Active, not recruiting
MD Anderson League City
Nassau Bay, Texas 77058
Active, not recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Active, not recruiting
MD Anderson in Sugar Land
Sugar Land, Texas 77478
Active, not recruiting
MD Anderson in The Woodlands
The Woodlands, Texas 77384
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

* Oligometastatic solid tumors (see protocol for relevant disease sites) patients (=< 5 metastatic lesions at the time of study entry) * Candidate for definitive local therapy to all sites of active disease per the discretion of the treating physicians * No more than 4 prior lines of systemic therapy administered to treat metastatic disease * Pathologically confirmed diagnosis of cancer as specified in protocol * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) >= 500/mcL (performed within 6 weeks prior to study enrollment)
* Platelets >= 25,000/mcL (performed within 6 weeks prior to study enrollment)
* Hemoglobin >=7 g/dL (performed within 6 weeks prior to study enrollment)
* Serum total bilirubin =< 1.5 mg/dl (except for subjects with Gilbert syndrome, who may have total bilirubin < 3.0 mg/dl) OR direct bilirubin =< upper limit normal (ULN) for subjects with total bilirubin levels > 1.5 mg/dl (performed within 6 weeks prior to study enrollment)
* Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) =< 3 X ULN OR =< 5 X ULN for subjects with liver metastases (performed within 6 weeks prior to study enrollment)

Exclusion Criteria

Exclusion Criteria:

* Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy
* Metastatic effusion (e.g. pleural effusion or ascites). Note that patients with an effusion that is too small to sample will be eligible for the trial
* Diffuse metastatic processes including leptomeningeal disease, diffuse bone marrow involvement, and peritoneal carcinomatous, which by the discretion of the treating physician cannot be treated definitively
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* In the event that a curative systemic option exists for metastatic disease from a given disease site. First-line metastatic patients (those patients who have had no prior lines of systemic therapy targeting their metastatic disease) are only eligible for enrollment if they have completed their curative systemic therapy per the judgment of the treating oncologist and have persistent disease
* Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit

* Female subject of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation
* Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Additional diagnosis of another primary malignancy outside of the malignancy being treated on trial that per the discretion of the treating physicians and investigational team offers a substantial risk to the patient's life (e.g. primary lung cancer definitively treated in the past 6 months would offer a significant risk to the patient's life, while a basal cell carcinoma treated with local excision would not)

NCT ID

NCT03599765

Date Trial Added

2018-07-26

Updated Date

2024-08-21