Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Recruiting · NCT05772481 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centre Paul Strauss
View the official record on ClinicalTrials.gov →Interventions studied
PET-MRI
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Institut de cancérologie Strasbourg Europe - Strasbourg, France