💬In plain words
What the trial is, and whether it could suit you
With 50 patients included, this trial would be the largest pilot study evaluating the value of MRI PET in locally advanced rectal cancer. On the other hand, it would be the only pilot study performing several MRI PET during neoadjuvant treatment. Presumably, the response assessed at the 2nd MRI PET (before cycle 4 or induction chemotherapy) would be predictive of the overall response at the end of neoadjuvant treatment. Then, it would be possible to predict precociously the tumor response.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) 0 to 2
* Histologically proven rectal cancer
* clinical tumor classification (cT) : cT3 - cT4 or all T / N+ / M0
* Tumor resectable or considered resectable after chemoradiotherapy
* Decision chemotherapy followed by neoadjuvant chemoradiotherapy decided at the organ Multidisciplinary Meeting
* Absence of distant metastases
* Adequate contraception for women of childbearing potential
* Free, signed and informed consent
* For women of childbearing potential : negative pregnancy test
Exclusion Criteria:
* Subject with Uncontrolled diabetes
* Contraindication to surgery
* Contraindication to MRI
* Contraindication to PET scan
* Contraindication to chemotherapy
* History of pelvic radiotherapy
* History of major co-morbidity that may prevent treatment and no active infection (HIV or chronic hepatitis B or C)
* Colloid (mucinous) adenocarcinoma
* Presence of distant metastases
* Contraindication to 5-FluoroUracil (FU), oxaliplatin or irinotecan
* History of known Gilbert's disease
* Patient with known UGT1A1 genotype
* Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
* Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
* Medical history of angina or myocardial infarction.
* Active progressive infection or any other serious medical condition that could compromise the administration of the treatment
* Other concurrent cancer, or medical history of cancer other than treated in situ cervical carcinoma or basal cell carcinoma or squamous cell carcinoma
* Patient enrolled in another clinical trial testing an investigational agent
* Pregnant or breastfeeding woman
* Persons deprived of their freedom or under guardianship or incapable of giving consent
* Any psychological, familial, sociological or geographic condition that may interfere with the study protocol or follow-up schedule
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