Adult With Intermediate Low or Mid Rectal AdenocarcinomaPhase 3TRESORNCT06402864
Evaluation Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
A Phase 3 study testing contact X-ray brachytherapy (CXB) in people with Adult With Intermediate Low or Mid Rectal Adenocarcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 11 sites in France.
Trial summary
Indication : Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy (TNT) potentially eligible for rectal preservation. Primary objective is to assess efficacy of contact X-ray brachytherapy (CXB) in addition to TNT in order to increase survival with organ… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Adult With Intermediate Low or Mid Rectal Adenocarcinoma
- What is being tested?
- contact X-ray brachytherapy (CXB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 11 sitesFrance
- Study dates
- 26 Mar 2024to 15 Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Institut Sainte Catherine
Avignon, France, 84918
Laurent Mineur, Dr, +33 4 90 27 61 88, l.mineur@isc84.org
- Recruiting
Centre Léon Bérard
Lyon, France, 69008
Jessica Serrand, Dr, +33 4 78 78 29 36, jessica.serrand@lyon.unicancer.fr
- Recruiting
Centre de radiotéhrapie Charcot
Lyon, France, 69110
Fanny Lamberth, Dr, +33 4 37 53 87 23, lamberth.fanny@laposte.net
- Recruiting
Centre d'oncologie et de radiothérapie
Mâcon, France, 7100
Nicolas Barbet, Dr, +33 4 26 68 67 67, barbet71@wanadoo.fr
- Recruiting
Hôpital Européen
Marseille, France, 13003
Yves Rinaldi, Dr, Y.RINALDI@hopital-europeen.fr
- Recruiting
Centre de Haute Energie
Nice, France, 06000
Audrey Claren, Dr, +33 4 93 53 87 00, audrey.claren@che-nice.com
- Recruiting
Centre Antoine Lacassagne
Nice, France, 06189
David Baron, Dr, +33 4 92 03 12 69, David.BARON@nice.unicancer.fr
- Recruiting
CHU de Saint Etienne
Saint-Etienne, France, 42270
Nicolas Vial, Dr, +33 4 77 91 71 02, nicolas.vial@chu-st-etienne.fr
- Recruiting
Institut de cancérologie de l'Ouest
Saint-Herblain, France, 44800
Emmanuel Rio, Dr, +33 2 40 67 99 00, Emmanuel.rio@ico.unicancer.fr
- Recruiting
Institut Gustave Roussy
Villejuif, France, 94805
Jérome Durand Labrunie, Dr, 0142116744, Jerome.durand-labrunie@gustaveroussy.fr
- Recruiting
Orlam-Bayard
Villeurbanne, France, 69100
Nicolas Barbet, Dr, +33426686767, barbet71@wanadoo.fr
About this study
Official title: Multicenter Randomized Phase III Trial Evaluating Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
Indication : Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy (TNT) potentially eligible for rectal preservation.
Primary objective is to assess efficacy of contact X-ray brachytherapy (CXB) in addition to TNT in order to increase survival with organ preservation (OP), in selected intermediate risk group of rectal adenocarcinomas (size from 3.1 to 6 cm, cT2N1 or T3N0-1, M0).
Read the detailed description
It is an open label phase III randomized controlled clinical trial comparing 2 arms:
- Control arm A consists in TNT regimen, with an induction chemotherapy Modified FOLFIRINOX (mFOLFIRINOX) 6 cycles over 12 weeks, followed by nCRT 50 Gy over 5 weeks with concomitant capecitabine (CAP50 Gy).
- Experimental arm B consists in addition of three fractions of CXB every two weeks between end of mFOLFIRINOX and nCRT.
Clinical, endoscopic and radiological evaluation will be performed 7 weeks after the end of nCRT in both arms:
- In case of cCR, local excision or surveillance will be proposed to patients regarding center choice
- In the absence of cCR patients will be treated by TME, followed by adjuvant chemotherapy (mFOLFOX 6 cycles or capecitabine 3 cycles over 12 weeks).
- Being tested
- contact X-ray brachytherapy (CXB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contact X-ray brachytherapy (CXB)Radiation
3 fractions of contact X-ray brachytherapy (CXB) every two weeks before neoadjuvant chemo radiotherapy (nCRT).
| Study group | Role | What they receive |
|---|---|---|
| control arm A | No intervention | Control arm A consists in TNT regimen, with an induction chemotherapy Modified FOLFIRINOX (mFOLFIRINOX) 6 cycles over 12 weeks, followed by neoadjuvant chemo radiotherapy (nCRT) 50 Gy over 5 weeks with concomitant capecitabine (CAP50 Gy). |
| Experimental arm B | Experimental | Experimental arm B consists in addition of three fractions of CXB every two weeks between end of mFOLFIRINOX and nCRT Receives: Radiation: contact X-ray brachytherapy (CXB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival with organ preservation
defined as a rectum intact, owing to:
- no radical TME,
- no locoregional regrowth unless amenable to limited curative (R0) salvage surgery by local excision (LE), and no permanent stoma (including a never reversed protective stoma, or a stoma owing to toxicities and/or poor functional outcomes).
Measured: at the end of the study,15 months after the first inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start26 Mar 2024
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult With Intermediate Low or Mid Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is an open label phase III randomized controlled clinical trial comparing 2 arms: * Control arm A consists in TNT regimen, with an induction chemotherapy Modified FOLFIRINOX (mFOLFIRINOX) 6 cycles over 12 weeks, followed by nCRT 50 Gy over 5 weeks with concomitant capecitabine (CAP50 Gy). * Experimental arm B consists in addition of three fractions of CXB every two weeks between end of mFOLFIRINOX and nCRT.
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérome Durand Labrunie, Dr, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402864
- Sponsor's protocol ID
- 2023-506885-30-00
- Other IDs
- 2023/3684, 2023
- Acronym
- TRESOR
- Status last verified
- Nov 2025
- First submitted
- 3 May 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Phase III Trial Evaluating Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06402864
- Acronym / sponsor ID
- TRESOR / 2023-506885-30-00
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Indication : Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy (TNT) potentially eligible for rectal preservation.
Primary objective is to assess efficacy of contact X-ray brachytherapy (CXB) in addition to TNT in order to increase survival with organ preservation (OP), in selected intermediate risk group of rectal adenocarcinomas (size from 3.1 to 6 cm, cT2N1 or T3N0-1, M0).
Detailed description
It is an open label phase III randomized controlled clinical trial comparing 2 arms:
- Control arm A consists in TNT regimen, with an induction chemotherapy Modified FOLFIRINOX (mFOLFIRINOX) 6 cycles over 12 weeks, followed by nCRT 50 Gy over 5 weeks with concomitant capecitabine (CAP50 Gy).
- Experimental arm B consists in addition of three fractions of CXB every two weeks between end of mFOLFIRINOX and nCRT.
Clinical, endoscopic and radiological evaluation will be performed 7 weeks after the end of nCRT in both arms:
- In case of cCR, local excision or surveillance will be proposed to patients regarding center choice
- In the absence of cCR patients will be treated by TME, followed by adjuvant chemotherapy (mFOLFOX 6 cycles or capecitabine 3 cycles over 12 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is an open label phase III randomized controlled clinical trial comparing 2 arms: * Control arm A consists in TNT regimen, with an induction chemotherapy Modified FOLFIRINOX (mFOLFIRINOX) 6 cycles over 12 weeks, followed by nCRT 50 Gy over 5 weeks with concomitant capecitabine (CAP50 Gy). * Experimental arm B consists in addition of three fractions of CXB every two weeks between end of mFOLFIRINOX and nCRT.
| Arm | Type | Receives |
|---|---|---|
| control arm A | No intervention | –Control arm A consists in TNT regimen, with an induction chemotherapy Modified FOLFIRINOX (mFOLFIRINOX) 6 cycles over 12 weeks, followed by neoadjuvant chemo radiotherapy (nCRT) 50 Gy over 5 weeks with concomitant capecitabine (CAP50 Gy). |
| Experimental arm B | Experimental | Radiation: contact X-ray brachytherapy (CXB)Experimental arm B consists in addition of three fractions of CXB every two weeks between end of mFOLFIRINOX and nCRT |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contact X-ray brachytherapy (CXB)3 fractions of contact X-ray brachytherapy (CXB) every two weeks before neoadjuvant chemo radiotherapy (nCRT). | Radiation | Experimental arm B |
Primary outcome
Survival with organ preservation
Time frame: at the end of the study,15 months after the first inclusion
defined as a rectum intact, owing to: * no radical TME, * no locoregional regrowth unless amenable to limited curative (R0) salvage surgery by local excision (LE), and no permanent stoma (including a never reversed protective stoma, or a stoma owing to toxicities and/or poor functional outcomes).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jérome Durand Labrunie, Dr principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing contact X-ray brachytherapy (CXB) in people with Adult With Intermediate Low or Mid Rectal Adenocarcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérome Durand Labrunie, Dr (01 42 11 67 44, Jerome.durand-labrunie@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival with organ preservation (time frame: at the end of the study,15 months after the first inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.