Timing of chemo could be key in colon cancer fight
NCT ID NCT02572141
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving chemotherapy both before and after surgery (perioperative) is better than only after surgery for people with advanced colon cancer. About 738 participants will be randomly assigned to one of two groups. The goal is to see if the perioperative approach helps more people stay cancer-free for three years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 738 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2015
- Expected to finish
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Apr 2031
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 70 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. Willing and able to provide written informed consent. 2. Histological or cytological documentation of adenocarcinoma of the colon (≥ 15 cm from the anal verge). 3. Determined preoperatively by either spiral or multidetector CT: high risk T3 (tumor disruption of muscle wall and extension into pericolic fat with more than 5 mm protrusion into adjacent mesenteric fat) or T4 (tumor penetrates to the surface of the visceral peritoneum or directly invades or is adherent to adjacent organs or structures). 4. Male or female subjects \> 18 years \< 70 of age. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. CT or MRI scans (done within 30 days of registration) of the chest, abdomen and pelvis all without clear evidence of distant metastatic (M1) disease. 7. Non complicated primary tumor (obstruction, perforation, bleeding). 8. No previous any systemic anticancer therapy for colon cancer disease. 9. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Exclusion Criteria: 1. Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization. 2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment. 3. Heart failure grade III/IV (NYHA-classification). 4. Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure. 5. Subjects with known allergy to the study drugs or to any of its excipients. 6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. 7. Breast- feeding or pregnant women 8. Lack of effective contraception.
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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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The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
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Other studies related to the condition(s) this trial covers.
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