Using blood tests to improve treatment for colorectal cancer patients
Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer
This study is testing if giving standard chemotherapy to colorectal cancer patients with detectable tumor DNA after surgery can help them stay cancer-free longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Trial ID | NCT03748680 on ClinicalTrials.gov |
What this trial studies
This phase II interventional trial investigates the effectiveness of adjuvant chemotherapy in patients with colorectal cancer who have detectable circulating tumor DNA (ctDNA) after surgery. The study aims to determine if administering standard chemotherapy can enhance disease-free survival in patients who typically would not receive such treatment. Participants will be randomly assigned to receive either standard chemotherapy or an intensified follow-up schedule. The trial also seeks to explore the molecular response to chemotherapy in patients with detectable ctDNA post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone radical resection for stage I or II colorectal cancer and have detectable ctDNA in their postoperative plasma.
Not a fit: Patients who do not have detectable ctDNA post-surgery or who are not clinically eligible for adjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates for colorectal cancer patients with residual disease after surgery.
How similar studies have performed: Other studies have shown promising results using ctDNA analysis to guide treatment decisions in cancer care, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Surgically removed Adenocarcinoma of the colon or rectum * Pathologically stage I or II disease, and radical resection * Detectable ctDNA in two weeks postoperative plasma sample * No indication for adjuvant chemotherapy according to DCCG guidelines (website) * Age at least 18 years * ECOG performance status 0-2 * Clinically eligible for adjuvant chemotherapy 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 and abdomen * Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy * Previous treatment with 5FU or oxaliplatin * Neuropathy NCI 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
Where this trial is running
Aalborg and 3 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Herlev Hospital — Herlev, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Study coordinator: Karen-Lise G Spindler, Professor
- Email: k.g.spindler@rm.dk
- Phone: 0045 7846 2535
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.