New X-Ray technique could help rectal cancer patients avoid colostomy
NCT ID NCT06402864
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding contact X-ray brachytherapy (a precise, high-dose radiation) to standard chemotherapy and radiation can help people with intermediate-stage rectal cancer keep their rectum instead of needing surgery to remove it. The study will enroll 212 adults whose tumors are 3.1 to 6 cm and have not spread. The goal is to see if more patients can avoid a permanent colostomy and live without the cancer coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- contact X-ray brachytherapy (CXB)
- What this could lead to
- If successful, this could allow many patients with intermediate rectal cancer to avoid removal of the rectum and a permanent colostomy, preserving normal bowel function.
- What could go wrong
- This is a phase 3 trial, but results are not yet known. The added radiation may cause more side effects, and some patients may still need surgery or a stoma.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 212 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Jun 2030
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 99 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: * Patient with histologically proven rectal adenocarcinoma * Intermediate risk factors: size ≥ 3.1 cm and ≤ 6 cm, \< 66% circumference, cT2N1 or T3N0-1, M0 at diagnostic. * Accessible by digital rectal exam, distal or middle rectum (\<11 cm from anal verge), not significantly involving the anal canal (external sphincter not involved) at diagnostic. * Operable patient * Patient who is about to start mFolfirinox chemotherapy. The registration is possible before, during or at the end of 4 cycles of mFolfirinox chemotherapy * Age ≥ 18 years * WHO status 0 or 1 at diagnosis * Biological values within the following limits: Total Bilirubin ≤ 1.5 times the upper limit of normal (ULN); ASAT and ALAT ≤ 5 N; Creatinine ≤ 1.5 N and creatinine clearance\> 60 ml/min; Neutrophils ≥ 1.5. 109 / L; Platelets ≥ 150. 109 / L; Hemoglobin ≥ 9 g / dL (patients can be included even if they have been transfused); Albuminemia≥30g / L before starting mFolfirinox chemotherapy; * Women of childbearing potential must have a negative serum β-HCG pregnancy test within 15 days prior to the administration of the first study treatment or urine pregnancy 72 hours prior to the administration of the first study treatment. * Sexually active women of childbearing potential must agree to use a highly effective method of contraception, * Sexually actives males patients must agree to use condom during the study and for at least 6 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception for the same duration. * Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. * Patients must be affiliated to a social security system or beneficiary of the same Exclusion Criteria: * Other cancer in the 5 years prior to start m Folfirinox chemotherapy or concomitant (except in situ cancer of the cervix, or basal cell carcinoma of the skin). * History of pelvic irradiation or pelvis surgery * Early tumor (T1-2N0, size \< 3.1 cm) or advanced tumor (T3 \> 6cm of circumference, T4, N2, M1) at diagnostic * Patient who stopped mFolfirinox after 3 cycles or less * Dihydropyrimidine dehydrogenase (DPD) deficiency. The blood uracil level must be measured at screening. The uracilemia dosing result is mandatory prior the inclusion of patient. * Given the oxaliplatin-related risk of prolongation of QT, patient with hypokalemia less than normal, hypomagnesemia, hypocalcemia, and QT/QTc interval longer than 450 msec for men and longer than 470 msec for women on the inclusion ECG should not be allowed at diagnostic. * Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia). * Unbalanced serious illness, underlying infection likely to prevent the patient from receiving treatment current pregnancy (obligatory pregnancy test at baseline) or breastfeeding. * Psychiatric illness compromising the understanding of information or the conduct of the study. * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent. * Inability to sign informed consent or to undergo medical follow-up of the test for geographical, social or psychological reasons. * Pregnant or breastfeeding women * No other anti-tumour prior treatments (chemotherapy, hormone therapy, biologic response inhibitors, targeted therapy) may be used for rectal adenocarcinoma. All live vaccines are prohibited before starting mFolfirinox chemotherapy. * The combination of warfarin (Coumadine®) with an mFOLFIRINOX regimen, FOLFOX or capecitabine is not recommended. It is preferable to use heparin or LMWH. If warfarin cannot be avoided, more frequent monitoring of prothrombin ratio and INR is necessary. * Pimozide (Orap®), and cisapride (Prepulsid®) are formally contraindicated: increased risk of ventricular arrhythmias, especially torsades de pointes before starting mFolfirinox chemotherapy * Known history of hypersensitivity to, fluorouracil, capecitabine, oxaliplatin, irinotecan, folinic acid, or to any of their excipients, according to the SmPCs of these products. * Recent or concomitant treatment with brivudine, according to the SmPC of fluorouracile and of capecitabine before starting mFolfirinox chemotherapy; * Chronic inflammatory bowel disease and/or bowel obstruction and in case of concomitant use with St John's Wort, according to the SmPC of irinotecan before starting mFolfirinox chemotherapy; * Peripheral sensory neuropathy with functional impairment prior to first treatment, according to the SmPC of oxaliplatin before starting mFolfirinox chemotherapy
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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
11 sites. 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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CHU de Saint Etienne
RECRUITINGSaint-Etienne, France, 42270, France
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Centre Antoine Lacassagne
RECRUITINGNice, France, 06189, France
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Centre Léon Bérard
RECRUITINGLyon, France, 69008, France
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Centre d'oncologie et de radiothérapie
RECRUITINGMâcon, France, 7100, France
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Centre de Haute Energie
RECRUITINGNice, France, 06000, France
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Centre de radiotéhrapie Charcot
RECRUITINGLyon, France, 69110, France
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Hôpital Européen
RECRUITINGMarseille, France, 13003, France
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Institut Gustave Roussy
RECRUITINGVillejuif, France, 94805, France
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Institut Sainte Catherine
RECRUITINGAvignon, France, 84918, France
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Institut de cancérologie de l'Ouest
RECRUITINGSaint-Herblain, France, 44800, France
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Orlam-Bayard
RECRUITINGVilleurbanne, France, 69100, France