This trial (molecular characterization trial) focuses on rectal cancer, a common cancer that is treated with radiotherapy (RT) as standard of care and represents a setting in which to study the effects of RT on the immune system.
Histologically confirmed diagnosis of adenocarcinoma of the rectum
Age ≥ 18 years
ECOG performance status 0-1
cT2-T3N0 or cT1-3N1 or cT4 or cN2
Recurrent rectal cancer
Primary unresectable rectal cancer is defined as a primary rectal tumor which, on the basis of either physical exam or pelvic MRI, is deemed to be adherent or fixed to adjacent pelvic structures (en bloc resection will not be achieved with negative margins).
Patients who have received prior pelvic radiotherapy
Patients with prior allogenic stem cell or solid organ transplantation.
Single group
Short Course Radiation Therapy (scRT)
RadiationEligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days (fractions) for their localized rectal cancer. Research bloods stool and tissue will be collected at three time points: Baseline, end of radiation therapy and at surgery.
Total Mesenteric Excision (TME)
Procedure/SurgerySubjects are expected to undergo total mesenteric Excision(TME) even if subjects have achieved complete response by imaging.TME is a specific surgical technique used in the treatment of rectal cancer in which the bowel with the tumor is entirely removed along with surrounding fat and lymph nodes.
Number of tissue biopsies obtained from treated patients
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Number of tissue biopsies obtained from treated patients
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Number of tissue biopsies obtained from treated patients
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Number of research specimens obtained before RT.
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
Changes in tumor morphology from pre-treatment and post-treatment MRI will be measured.
All patients will have pre-treatment and post-treatment multi-modality MRI. Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the tumor morphology at each time point. Deep learning-based radiomics (DLR) was developed to extract deep information from multiple modalities of magnetic resonance (MR) images.
Changes in tumor morphology from pre-treatment and post-treatment CT will be measured.
All patients will have pre-treatment and post-treatment multi-modality planning CTs. Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the tumor morphology at each time point. Deep learning-based radiomics (DLR) was developed to extract deep information from multiple modalities of magnetic resonance (MR) images.
Changes in tumor texture from pre-treatment and post-treatment MRI will be measured.
All patients will have pre-treatment and post-treatment multi-modality MRI. Tumor texture analysis will be measured using dynamic contrast enhanced (DCE)-MRI. Tumor texture has made the most significant contribution in predicting response for patients receiving radiotherapy Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the tumor texture at each time point.
Changes in tumor texture from pre-treatment and post-treatment CT will be measured.
All patients will have pre-treatment and post-treatment multi-modality planning CTs. Tumor texture analysis will be measured using dynamic contrast enhanced (DCE)-MRI. Tumor texture has made the most significant contribution in predicting response for patients receiving radiotherapy Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the tumor texture at each time point.
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Weill Medical College of Cornell University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
