PET/MRI in Rectal Cancer
ConditionRectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this trial
The purpose of this study is to see which participants have a better treatment response using PET/MRI imaging to study the removed tumor, after they have received a total neoadjuvant therapy (TNT). The treatment choice of long course chemo-radiotherapy treatment will be determined by institutional policy.
The researchers will also be looking at whether this study could significantly improve the future management and quality of life of rectal cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically proven adenocarcinoma of the rectum.
Clinical stage 2-3 rectal adenocarcinoma, cT3/4N0/M0 or Tx N1-2/M0, within 16 cm from anal verge (lesion below the sacral promontory).
Patients deemed suitable to undergo TNT followed by surgical resection.
Male or female ≥ 18 years of age.
Disqualifiers
Patient receiving short course radiotherapy alone for rectal cancer.
Patient receiving standard TNT.
Patients with metastatic disease.
Prior pelvic radiotherapy or chemotherapy.
Trial design
Design model
Single group
Treatments tested in this trial
Total Neo-adjuvant Therapy
Radiation* TNT incorporates chemotherapy with concurrent chemoradiotherapy (CRT) in any order. * Radiotherapy includes 5000 cGy/25 fractions over 5 weeks. * Chemotherapy regimen for Concurrent CRT: Capecitabine * Chemotherapy regimens used with TNT are: FOLFIRINOX x 6 cycles, 8-9 courses FOLFOX or 5-6 courses of CAPEOX delivered over 4-6 months. * The chemotherapy regimen or the order of treatment will be decided at the discretion of the patient's medical oncologist
18FDG-PET/MRI scan
Other intervention18FDG-PET/MRI scan within 4 weeks of commencing chemo-radiation and within 1 - 2 weeks before radical rectal cancer surgery.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The primary endpoint of the study is pathological response (pCR) prediction with PET/MRI.
A 3-point scale will be used on PET/MRI assessment. When PET and MRI are concordant, the score remains unchanged. When MRI or PET are discordant, but one modality is definitive for complete response (e.g., MRI showing low intensity crescent at site of tumor or no uptake is identified on corresponding location on PET), a tumor regression grade (TRG) score of 1 will be assigned.
Time frame
Week 29 - Week 312
Correlation between PET/MRI reported pCR and complete(pCR) or incomplete response(non-pCR) to total neoadjuvant therapy determined by final pathology will be defined.
The pathologic response to the total neo-adjuvant therapy will be assessed generally using classification of tumor regression grade (TRG) defined by Mandard et al.
Time frame
Week 31Secondary outcomes
1
To evaluate the significance of PET/MRI compared to MRI to predict response to TNT.
MRI imaging performed before and after TNT and the post TNT scans will be compared to baseline to identify the degree of regression. This comparison to baseline imaging will be performed to avoid misinterpretation of pseudotumor (inflammatory changes within normal rectal wall adjacent to regressed tumor) as residual tumor.
Time frame
Week 29 - Week 31 (1 - 2 weeks before surgery)2
A feasibility study done to evaluate the benefit of using PET/MRI with respect to improved identification of the target and hence target delineation
Therapy plans are generated using image measures derived from standard radiotherapy plans or PET/MRI imaging. CT imaging is the standard imaging procedure used for radiotherapy treatment planning. In this clinical trial, a therapy plan will be generated from the initial PET/MRI imaging performed in the radiotherapy treatment position. This therapy plan will be compared with standard radiotherapy plans to evaluate the significance of using PET/MRI in radiotherapy treatment planning.
Time frame
Week 29 - Week 31 (1 - 2 weeks before surgery)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: