Optimizing treatment selection for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Precision oncology navigation with expert genomic review to guide therapy and survival

  This tests whether a centralized precision oncology navigator and expert review of NGS results increase the use of genome-informed therapies for people with stage IV breast, lung, colorectal, or bladder cancer.

  Recruiting UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT06896162

• Treatment of advanced cancers using CEA-targeted CAR-T cells

  This study is testing a new type of CAR-T cell treatment for people with advanced cancers that have a specific marker, to see if it is safe and how well it works for those who haven't had success with other treatments.

  Recruiting Phase 1 Zhejiang University · Hangzhou, Zhejiang · NCT06821048

• Upfront dose-reduced chemotherapy for older patients with metastatic colorectal cancer

  This study is testing whether giving lower doses of chemotherapy can help older patients with advanced colorectal cancer live longer and feel better compared to the standard full doses.

  Recruiting at 10 sites Phase 3 Leiden University Medical Center · 's-Hertogenbosch and 35 other locations · NCT06275958

• Testing MGC026 in patients with advanced solid tumors

  This study is testing a new treatment called MGC026 to see if it can help adults with advanced solid tumors that can't be removed or have spread to other parts of the body.

  Recruiting at 12 sites Phase 1 MacroGenics · Los Angeles, California and 11 other locations · NCT06242470

• FOG-001 treatment for advanced or metastatic solid tumors

  This study is testing a new drug called FOG-001 to see if it can help people with advanced solid tumors, especially those with certain genetic changes, when traditional treatments aren't working.

  Recruiting at 32 sites Phase 1/2 Parabilis Medicines, Inc. · Phoenix, Arizona and 32 other locations · NCT05919264

• Evaluating PC14586 for advanced solid tumors with a specific mutation

  This study is testing a new oral medication called PC14586 to see if it can help people with advanced solid tumors that have a specific mutation in the TP53 gene.

  Recruiting at 71 sites Phase 1/2 PMV Pharmaceuticals, Inc · Irvine, California and 75 other locations · NCT04585750

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.