Clinical trial NCT05609149: MRI Features in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer
Official title: Risk Criteria Based on MRI Features Outperform Radiographic TNM Staging in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer:A Single-Center, Open-Label, Retrospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Rectal cancer
Neoadjuvant treatment
Mesorectal fascia
Extramural vascular invasion
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rectal cancer patients with T3Nx or T1-3N+ at initial diagnosis.

Brief summary: This study investigates whether risk criteria based on MRI features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by NCCN guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatmen than radiographic TNM staging in the patients who received neoadjuvant therapy.

Detailed description: There is a lack of international consensus on the choice of preoperative treatment for patients with rectal cancer. Existing guidelines decide whether to administer preoperative therapy to patients with rectal cancer mainly based on the TNM system developed by AJCC/UICC, however, radiographic TNM staging is unsatisfactory in predicting the prognosis of patients with rectal cancer, due to inflammatory and fibrotic responses TNM re-staging is less accurate than pre-treatment. Studies have shown that high-resolution magnetic resonance imaging(MRI) accurately predicted pathologic findings such as CRM involvement, EMVI and TD and patients with MRI-detected CRM involvement, EMVI and TD are at risk for local and distant recurrence as well as poor overall survival. This retrospective study is designed to was to evaluate whether risk criteria based on MRI features can be used as a basis for neoadjuvant treatment decisions and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatment than radiographic TNM staging. Patients with MRI-detected circumferential resection margin (CRM) involvement, extramural venous invasion (EMVI), or tumor deposits (TD) were defined as MRI high-risk.

Eligibility criteria: Inclusion Criteria:

1. Underwent primary rectal adenocarcinoma resection
2. Received MRI scan before surgery
3. Willing and able to provide written informed consent for participation in this study.
4. Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (\<12 cm from the anal verge).
5. Clinical stage of T3Nx or T1-3N+ at initial diagnosis
6. Non-complicated primary tumor (complete obstruction, perforation, bleeding).
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

1. Treated with transanal local excision
2. with distant metastases at the time of initial diagnosis
3. Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
4. Subjects with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), myocardial infarction (MI), Transient Ischemic Attacks (TIA), or cerebralvascular accident (CVA).

Primary outcomes:
measure: 3-year event-free survival rate
timeFrame: 3 years after the surgery
Secondary outcomes:
measure: 3-year overall survival rate
timeFrame: 3 years after the surgery
measure: Local recurrence
timeFrame: 3 years after the surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References: