Evaluating PET-MRI for assessing treatment response in advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of PET-MRI in assessing the response of locally advanced rectal adenocarcinoma to neoadjuvant treatment. It will involve 50 patients and is designed to be the largest pilot study of its kind, performing multiple PET-MRI scans during treatment. The study seeks to identify predictive parameters that can indicate tumor response to chemotherapy and chemoradiotherapy before surgery. By comparing the results of the second PET-MRI scan with the final treatment outcomes, researchers hope to improve the accuracy of treatment response assessments.

Why it matters

Who can join: the full rules

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's running

• Institut de cancérologie Strasbourg Europe
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Manon VOEGELIN
• Email: promotion-rc@icans.eu
• Phone: +33 6 68 33 95 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.