Optimizing treatment selection for advanced colorectal cancer
OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach
This study tests if using blood tests to check for tumor DNA can help doctors choose better chemotherapy options for people with advanced colorectal cancer after their initial treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Aarhus N and 1 other locations) |
| Trial ID | NCT04680260 on ClinicalTrials.gov |
What this trial studies
This study investigates whether analyzing circulating tumor DNA (ctDNA) can improve adjuvant chemotherapy decisions in patients with advanced colorectal cancer. It is an open-label, randomized phase II trial comparing ctDNA-guided treatment to standard of care after local treatment for metastatic colorectal cancer. Patients will be randomized in a 1:1 ratio to receive either standard treatment or ctDNA-guided therapy, which may include escalation or de-escalation of chemotherapy regimens based on ctDNA analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic colorectal cancer who are eligible for radical treatment and adjuvant chemotherapy.
Not a fit: Patients with extensive disease requiring cytoreductive surgery or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with advanced colorectal cancer.
How similar studies have performed: Other studies have shown promise in using ctDNA for treatment guidance, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Radical intended treatment for metastatic spread from CRC, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC) * No evidence of further disease based on pre-treatment work-up according to SOC * Age at least 18 years * Eastern Cooperative Oncology Group performance status 0-2 * Clinically eligible for adjuvant triple CT at investigators decision. * Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 mL/min) * Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable * Written and verbally informed consent Exclusion Criteria: * Radiological evidence of distant metastasis, by CT- chest, abdomen, and pelvis * Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy * Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade \> 1 * Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri * Pregnant (positive pregnancy test) or breast feeding women * Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine
Where this trial is running
Aarhus N and 1 other locations
- Department of Oncology, Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
- Department pf Oncology, Vejle Hospital — Vejle, Denmark (Recruiting)
Study contacts
- Principal investigator: Karen-Lise G Spindler, Professor — Department of Oncology, Aarhus University Hospital
- Study coordinator: Karen-Lise G Spindler, Professor
- Email: k.g.spindler@rm.dk
- Phone: +4591167244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.