Clinical trial NCT05772481: Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Official title: Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with histologically proven rectal cancer with an indication for induction chemotherapy followed by neoadjuvant chemoradiotherapy

Brief summary: 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.

Detailed description: The management of localized rectal cancer is done in two phases. The first phase, medical, combines a possible first chemotherapy, followed by a concomitant chemoradiotherapy. The second phase, 6 to 8 weeks later, consists of surgery of the rectum.

Magnetic resonance imaging (MRI) of the pelvis allows staging of the tumor and its possible lymph node extensions. MRI can also be used to assess tumor response after the first phase of treatment and before surgery. But MRI of the pelvis is partially imperfect.

PET-MRI is an examination that combines MRI with an injection of \[18 F\]fluorodeoxyglucose (18F-FDG). It is known to be more sensitive in assessing tumor stage and lymph node extensions compared to MRI and more sensitive in assessing tumor response before surgery.

The aim of this study is to determine predictive parameters for response to the first phase of treatment by accurately identifying the characteristics of tumors that have responded or not to treatment with chemotherapy and chemoradiotherapy.

Eligibility criteria: 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
* Adequate hematologic function
* Adequate liver function
* 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)
* Hypofractionated radiotherapy according to the Swedish protocol (25 Gy in 5 fractions)
* 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

Primary outcomes:
measure: Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of metabolic criteria.
timeFrame: At the surgery
measure: Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of MRI criteria.
timeFrame: At the surgery
measure: Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of anatomopathological criteria.
timeFrame: At the surgery
Secondary outcomes:
measure: Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of tumor volumes
timeFrame: At the PET MRI pretherapy (= PET MRI 1)
measure: Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of SUVmax values
timeFrame: At the PET MRI pretherapy (= PET MRI 1)
measure: Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of ADC values
timeFrame: At the PET MRI pretherapy (= PET MRI 1)
measure: Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta tumor volume
timeFrame: At the 2nd PET (PET2), up to 28 months
measure: Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta SUVmax values
timeFrame: At the 2nd PET (PET2), up to 28 months
measure: Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta ADC values
timeFrame: At the 2nd PET (PET2), up to 28 months
measure: Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta tumor volume
timeFrame: At the 3rd PET (PET3), up to 28 months
measure: Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta SUVmax values
timeFrame: At the 3rd PET (PET3), up to 28 months
measure: Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta ADC values
timeFrame: At the 3rd PET (PET3), up to 28 months
measure: Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta tumor volume
timeFrame: At the 4th PET (PET4), up to 28 months
measure: Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta SUVmax values
timeFrame: At the 4th PET (PET4), up to 28 months
measure: Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta ADC values
timeFrame: At the 4th PET (PET4), up to 28 months
measure: Propose standardized criteria to differentiate responders from non-responders
timeFrame: Data record throughout the study, up to 28 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
References: