Informations générales (source: ClinicalTrials.gov)
Multicenter Randomized Phase III Trial Evaluating Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
Interventional
Phase 3
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
mars 2024
juin 2030
12 septembre 2025
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 3.5 to 6 cm, cT2N1 or
T3N0-1, M0).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Jerome DURAND-LABRUNIE | 10/06/2026 14:25:05 | Contacter | ||
Critères
Tous
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
- 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
- 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