Clinical Trials

Inclusion Criteria:

- PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal
adenocarcinoma

- PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor

- PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation

- PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if
follow-up brain imaging after central nervous system (CNS)-directed therapy shows no
evidence of progression. No known peritoneal and/or omental metastases. If radiologic
studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is
recommended to verify the absence of peritoneal implants

- PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is
surgically amenable to resection, as determined by consultation and documentation with
surgeon or documentation of discussion in the institutional multi-disciplinary tumor
board where a surgeon confirms resectability. Patients with unresectable primary
tumors are not eligible

- PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease
based on review by local medical team of baseline radiographic imaging obtained prior
to initiation of systemic therapy.

- Sites of metastatic disease must be radiographically evident, but pathologic
confirmation is not required.

- Liver-only metastatic disease is NOT permitted. For patients with liver
metastases, there must be at least one other site of metastasis in addition to
the liver to be eligible for this study.

- Metastatic lesions must be amenable to any combination of surgical resection,
microwave ablation, and/or stereotactic ablative body radiation therapy (SABR).
SABR is required for at least one lesion. Therefore, the patient must be seen by
a radiation oncologist in consultation to verify eligibility.

- Single sites include:

- Each hemiliver (right and left), each lobe of the lungs, each adrenal gland,
lymph nodes amenable to a single resection or treatment in a single SABR
field, bone metastases amenable to treatment in a single SABR field

- PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response
Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

- PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be
administered prior to pre-registration

- REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression
during systemic therapy prior to registration

- REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or
benefit of HAIP therapy is undefined

- REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1

- REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line
systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a
maximum of 24 weeks (6 months)

- REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must
have been completed at least 12 months prior to diagnosis of metastatic disease

- REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an
agent or treatment that has known genotoxic, mutagenic, and teratogenic effects.

* Therefore, for women of childbearing potential only, a negative pregnancy test done
=< 14 days prior to registration is required

- REGISTRATION (STEP 1): Age >= 18 years

- REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status:
0-2

- REGISTRATION (STEP 1): Absolute neutrophil count (ANC) >= 1,500/mm^3

- REGISTRATION (STEP 1): Platelet count >= 50,000/mm^3

- REGISTRATION (STEP 1): Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated
(calc.) creatinine clearance >= 30 mL/min

* Calculated using the Cockcroft-Gault equation

- REGISTRATION (STEP 1): Total bilirubin =< 1.5 x ULN

- REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic
transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamate pyruvate
transaminase [SGPT]) =< 3.0 x ULN

* In the event of metastatic liver disease, =< 5 x ULN

- REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on
effective anti-retroviral therapy with undetectable viral load within 6 months are
eligible for this trial. Note: HIV testing is not required for eligibility

- REGISTRATION (STEP 1): No other planned concurrent investigational agents while on
study

Exclusion Criteria:

- N/A

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/6/23. Questions regarding updates should be directed to the study team contact.