Rectal Cancer
Conditions
Keywords
rectal cancer, neoadjuvant therapy
Brief summary
This study proposeto integrate a variety of imaging quantitative indicators to establish a new MRI-based tumor response regression(mrTRG) classification method. The accuracy of the established mrTRG classification method according pathology TRG(pTRG) will be tested. The ability of the established mrTRG classification method to predict prognosis will also be tested.
Detailed description
The study included two part: one is a retrospective single-center cohort for analyzing quantitative MRI factors associated with pTRG, from which a new MRI-based tumor response regression(mrTRG) classification method will be established. The other is a prospective multi-center cohort for testing the accuracy of the established mrTRG classification according to pTRG; and also for validating the established mrTRG classification associated with survival.
Interventions
DIAGNOSTIC_TESTpelvic MRI for establishing new mrTRG method
they will received two pelvic MR examinations before and after neoadjvant therapy. The MRI before neoadjvant therapy is considered as baseline MRI, which is usually taken within 3 weeks before NAT. The MRI after neoadjvant therapy is considered as preoperative MRI, which is usually taken within 3-8 weeks before NAT.
Sponsors
Capital's Funds for Health Improvement and Research (2020-1- 2151).
Peking University Cancer Hospital & Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* biopsy-proved primary rectal cancer * baseline MRI confirmed LARC (cT3 and/or cN+) * scheduled to take neoadjuvant therapy * receive baseline and preoperative pelvic MRI * receive TME surgery after NAT * have routine follow-up after the operation
Exclusion criteria
* history of malignancy or multiple primary cancers * receive surgery directly without NAT * don't receive TME surgery * don't complete NAT * simultaneous distant metastasis at the baseline diagnosis * lack of baseline or preoperative pelvic MRI * incomplete or unavailable pathological information * lost to follow-up within three months after surgery (lost since the first follow-up visit)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological tumor regression grade(pTRG) | within 2 weeks after surgery | pTRG is evaluated according to the AJCC system. pTRG0-1 is defined as good response, pTRG2 as moderate response, and pTRG3 as poor response. The pTRG is judged by two experienced pathologists working together. If there are any discrepancies, then a third senior pathologist is consulted for arbitration. there were any discrepancies, then a third senior pathologist was consulted. there were any discrepancies, then a third senior pathologist was consulted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| distant metastasis | 3 years from the data of surgery | Distant metastastic lesion detected by follow-up CT which will be performed every 3 month for the first two year and every 6 month since the third year |
| Death | 3 years from the data of surgery | all cause death |
| local recurrence | 3 years from the data of surgery | — |
Countries
China
Outcome results
None listed