A Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer (RESOLUTE)

Not Applicable

Recruiting

Conditions: metastatic colorectal cancer
Cancer - Bowel - Back passage (rectum) or large bowel (colon)
Cancer - Bowel - Small bowel (duodenum and ileum)

Registration Number: ACTRN12621001198819

Lead Sponsor: Cancer Council Victoria

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Inclusion:
-Metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery.
-Primary tumour must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry
-Imaging demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-6 months of standard first-line systemic treatment.
-3 to 10 metastatic lesions detected on CT +/- FDG-PET scan prior to first line systemic treatment AND on screening FDG-PET and CT scans:
o maximum of 3 lesions per organ except for the liver and lung
o maximum of 5 lesions in the lung
o no limit to number of liver lesions provided all are amenable to LAT
o maximum of 3 involved organs including a maximum of 2 lymph node stations.

-All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.

Exclusion Criteria

Exclusion:
-Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen’s disease or prostate cancer with a Gleason score =6.
-Presence of brain, peritoneal, omental or ovarian metastases
-Malignant pleural effusion or ascites.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of metastasis-directed local ablative therapies (LAT) following initial standard first-line systemic treatment as measured by Progression-Free Survival (PFS). [ PFS rate (by Investigator) at 12 months from enrolment]

Secondary Outcome Measures

Name	Time	Method
Efficacy of LAT following initial standard first-line systemic treatment as measured by Overall Survival (OS). [ At 12 months from enrolment and at study completion.];Efficacy of LAT following initial standard first-line systemic treatment as per imaging (RECIST) criteria. [ At 12 months from enrolment and at study completion];Systemic treatment-free interval. Patient medical records will be used to determine systemic treatment-free interval, which is defined as the total time period where systemic treatment is not being regularly administered from enrolment until the initiation of 2nd line systemic treatment. [ At study completion.];Rate of high-grade (Grades 3-5 according to CTCAE v5) toxicities. [ At study completion];Quality of life measures using patient questionnaires (EORTC QLQ-C30 and QLQ-CR29, LAT-specific PRO-CTCAE). This will be assessed as a composite outcome. [ At study completion]