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Multicenter randomized Phase III trial evaluating contact X-ray brachytherapy for rectal preservation in intermediate substage rectal adenocarcinoma (TRESOR)
EU CTIS ID: 2023-506885-30-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient with histologically proven rectal adenocarcinoma
- 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
- Age ≥ 18 years.
- WHO status 0 or 1 at diagnostic
- 3. If patients have lymph node involvement, this should be defined as : any lymph node with short axis ≥ 9 mm ; Lymph nodes 5 to 8 mm in short axis with at least two morphologic criteria ; Lymph nodes <5 mm and all three morphologic criteria The suspicious morphologic criteria include round shape, irregular borders, and heterogeneous signal intensity.
You likely can't join if
- Other cancer in the 5 years prior to start m Folfirinox chimiotherapy into the trial or concomitant (except in situ cancer of the cervix, or basal cell carcinoma of the skin).
- Peripheral sensory neuropathy with functional impairment prior to first treatment, according to the SmPC of oxaliplatin before starting mFOLFIRINOX chimotherapy.
- 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 or attenuated vaccines are prohibited before starting mFOLFIRINOX chemotherapy, during chemotherapy treatment and for up to 6 months afterwards.
- 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 before starting mFOLFIRINOX chimotherapy.
See the full eligibility criteria
Who can join
- Patient with histologically proven rectal adenocarcinoma
- 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
- Age ≥ 18 years.
- WHO status 0 or 1 at diagnostic
- 3. If patients have lymph node involvement, this should be defined as : any lymph node with short axis ≥ 9 mm ; Lymph nodes 5 to 8 mm in short axis with at least two morphologic criteria ; Lymph nodes <5 mm and all three morphologic criteria The suspicious morphologic criteria include round shape, irregular borders, and heterogeneous signal intensity.
- 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 chimotherapy;
- 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, or to abstain from sexual activity during the study and for at least 6 months after the last study treatment administration (and at least 15 months after the last oxaliplatin infusion). A woman is considered of childbearing potential following menarche and until becoming post-menopausal (≥ 12 months of non-therapy-induced amenorrhea) unless permanently sterile. [...] Following methods are considered as unacceptable methods (non-exhaustive list): periodic abstinence (calendar, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus).
- 5. Patient eligible for treatment with mFOLFIRINOX chemotherapy. Inclusion is possible before, during or at the end of a minimum of 4 cycles of mFOLFIRINOX chemotherapy (in case of toxicity) or up to a maximum of 6 cycles.
- Sexually actives males patients must agree to use condom during the study and for at least 6 months after the last study treatment administration (and at least 12 months after the last oxaliplatin infusion).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
- Intermediate risk factors: size ≥ 3.1 cm and ≤ 6 cm, < 66% circumference, cT2N1 or T3N0-1, M0 at diagnostic.
What rules you out
- Other cancer in the 5 years prior to start m Folfirinox chimiotherapy into the trial or concomitant (except in situ cancer of the cervix, or basal cell carcinoma of the skin).
- Peripheral sensory neuropathy with functional impairment prior to first treatment, according to the SmPC of oxaliplatin before starting mFOLFIRINOX chimotherapy.
- 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 or attenuated vaccines are prohibited before starting mFOLFIRINOX chemotherapy, during chemotherapy treatment and for up to 6 months afterwards.
- 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 before starting mFOLFIRINOX chimotherapy.
- Pimozide (Orap®), and cisapride (Prepulsid®) are formally contraindicated: increased risk of ventricular arrhythmias, especially torsades de pointes before starting mFOLFIRINOX chimotherapy.
- History of pelvic irradiation or pelvis surgery
- Early tumor (T1-2N0, size < 3.1 cm) or advanced tumor (T3 > 6cm ᴓ, T4, N2, M1) at dignostic
- Dihydropyrimidine dehydrogenase (DPD) deficiency. The blood uracil level must be measured at screening. The uracilemia dosing result is mandatory prior the inclusion of patient. In patients with moderate to severe renal impairment, results should be interpreted with caution, and additional testing (e.g., DPYD gene genotyping) may be considered if the interpretation is uncertain.
- Patient who stopped mFolfirinox after 3 cycles or less
- 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.
- 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 chimotherapy.
- 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 chimotherapy.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.