Can a simpler chemo schedule tame colorectal cancer with fewer side effects?
NCT ID NCT02821559
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial tests whether giving the chemotherapy drugs raltitrexed and oxaliplatin every two weeks is as effective and less toxic than the standard every-three-week schedule in people with metastatic colorectal cancer who have not had prior chemotherapy. Some participants also receive the targeted drug bevacizumab. The study measures drug levels in the blood, tumor response, side effects, and survival to see if the biweekly approach could be a better option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of raltitrexed and oxaliplatin, with or without bevacizumab
- What this could lead to
- If successful, this could identify a safer, more convenient dosing schedule for this chemotherapy combination, potentially improving quality of life for people with metastatic colorectal cancer.
- What could go wrong
- This is a small Phase 2 trial, so results may not apply broadly. Raltitrexed has known toxicity risks, and the study does not aim to prove the combination works better than standard treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
37 people
The number who actually took part.
- Started
-
Aug 2012
- Finished
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Sep 2014
- Lead sponsor
-
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
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * performance status (ECOG-PS) of 0 or 1 * patient with histologically proven colorectal cancer with distant metastases * measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * life expectancy \> 12 months * signed written informed consent Exclusion Criteria: * prior chemotherapy at metastatic stage * presence of brain or meningeal metastases * other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix and squamous or basal cell carcinoma of the skin * preexisting peripheral neuropathy * known hypersensitivity to any component of the study treatment * any psychiatric condition compromising the understanding of information or conduct of the study * pregnancy, breast-feeding or absence of adequate contraception for fertile patients * patient under guardianship, curator or under the protection of justice
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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
-
CHRU de Besançon
Besançon, France
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Other studies related to the condition(s) this trial covers.
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