Blood test could guide stronger chemo for colon cancer
NCT ID NCT07821333
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing whether a blood test that detects tiny amounts of tumor DNA can guide chemotherapy after surgery for early colon cancer. The trial compares two chemotherapy regimens: an intensive one called FOLFOXIRI and a standard one called CAPOX. They want to see if the intensive treatment is better at clearing the tumor DNA from the blood. The study includes 45 patients with stage II or III colon cancer who test positive for this DNA after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FOLFOXIRI, an intensive combination chemotherapy regimen, compared with CAPOX, a standard chemotherapy regimen
- What this could lead to
- If intensive chemotherapy clears ctDNA better than standard treatment, doctors could use a simple blood test to decide who needs stronger chemotherapy after colon cancer surgery.
- What could go wrong
- This is a small Phase II trial with 45 patients, so it may not show a clear difference between the two treatments. Intensive chemotherapy can cause more side effects, and clearing ctDNA may not always mean the cancer is gone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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45 people
The number who actually took part.
- Started
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Jan 2022
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. CIRCULATE-SPAIN-01 trial written informed consent. 2. Age ≥ 18 years and ≤ 75 years. 3. Histologically confirmed diagnosis of operable stage II or stage III Colon Cancer. 4. Postoperative, ctDNA positive. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Normal organ functions, as follows: * Absolute neutrophil count (ANC) ≥ 1500/μL. * Platelets ≥ 100.000/μL. * Hemoglobin ≥ 9.0 g/dL OR ≥ 5.6 mmol/L. * Total bilirubin ≤ 1.5 x upper level of normality (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 x ULN. * Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 2.5 x ULN. Note: Synchronous primary tumours are accepted. Note: Patients with rectal cancer above the peritoneal reflection, who have not undergone postoperative chemotherapy or radiotherapy and who have risk factors, may be included in the trial. Exclusion Criteria: 1. Patients having a MicroSatellite Instability High (MSI-H) or MisMatch Repair Deficient (MMRd) tumor are excluded from the study (done according to standard clinical practice). 2. History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 3. Had an incomplete diagnostic colonoscopy and/or polyps' removal for patients in whom the remaining colon was not removed or explored. Note: Patients with intraoperative complete colonoscopy or early perioperative complete colonoscopy and/or patients with incomplete colonoscopy, but who do have a CT Colono or Intraoperative Colonoscopy, may be eligible to be recruited in the study. 4. Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage). 5. Current treatment with another investigational drug or participation in another investigational study. 6. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons. 7. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. 8. Inadequate contraception (male or female patients) if of childbearing or procreational potential. 9. Current clinically unresolved cardiovascular disease. 10. Acute or subacute intestinal occlusion or history of inflammatory bowel disease. 11. Pre-existing neuropathy \> grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment. 12. Has a known DihydroPyrimidine Dehydrogenase (DPD) deficiency. 13. Has a known Gilbert Syndrome or UGT1A1 homozygous \*28/\*28 germline variant. 14. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required. 15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C is required. 16. Has a known history of active Bacillus Tuberculosis (TB).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
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Hospital General Universitario de Valencia
Valencia, 46014, Spain
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Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
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Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Hospital del Mar
Barcelona, 08003, Spain
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