Could skipping radiation be just as effective for rectal cancer?
NCT ID NCT03875781
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using chemotherapy alone before surgery works as well as chemotherapy followed by radiation for people with locally advanced rectal cancer. About 540 adults with stage T3 or node-positive rectal cancer will take part. The goal is to see if avoiding radiation can maintain cancer control while reducing side effects.
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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 540 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2019
- Expected to finish
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Dec 2026
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 years and older
- 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: * Histologically proven middle or low rectal carcinoma, ≤ 10 cm from the anal verge on MRI (sagittal slide) * cT3N0 and/or cT1-T3N+ on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound), * Pretreatment predictive circumferential margin \> 2mm on pretreatment imaging work up (pelvic contrast enhanced MRI) * Patients must be 18 years old or older * A World Health Organization (WHO/ECOG) performance status of 0 or 1 * Informed consent signed * Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Exclusion Criteria: * Rectal tumor \> 10 cm from the anal verge on MRI (sagittal slide) * cT4 tumor on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound) or involvement of external sphincter * Circumferential margin ≤ 2 mm on pretreatment imaging work up (pelvic contrast enhanced MRI) * Metastatic disease * Prior pelvic irradiation or any contraindication to pelvic irradiation * Contraindication to oxaliplatin or irinotecan or 5FU based chemotherapy * Concomitant treatment with warfarin is contraindicated and warafarin must be replaced whenever possible to allow for inclusion. * Recent or concomitant treatment with brivudine is contraindicated * contraindications to 5-FU: complete and permanent insufficiency in dihydropyrimidine dehydrogenase, bone marrow insufficiency, chronic and severe infection * contraindication to irinotecan : inflammatory bowel disease, bilirubin serum level \> 3 times the upper limit of the normal rate, severe bone marrow insufficiency, WHO/ECOG performence status \> 2, * Concomitant treatment with millepertuis. * contraindication to oxaliplatin : \*bone marrow insufficiency before treatment initiation (neutrophil count \<2x109/L and/or platelet count \<100x109/L), peripheral neuropathy with permanent invalidity before treatment initiation * severe renal insufficiency (Creatinin clearance \<30 ml/min) * contraindications to folinic acid : Biermer anemia and other anemia related to B12 vitamin insufficiency * contraindications to capecitabin : severe renal insufficiency (Creatinin clearance \<30 ml/min), complete and permanent insufficiency in dihydropyrimidine dehydrogenase * live attenuated vaccine should not be used during and 6 months after preoperative treatment. * Previous colorectal cancer * Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for \>5 years * Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * protected adults * Pregnancy or breastfeeding * Patient with no national health or universal plan affiliation coverage.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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BENOIST
RECRUITINGLe Kremlin-Bicêtre, Île-de-France Region, 94275, France
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