Locally Advanced Rectal Cancer
Conditions
Brief summary
This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.
Detailed description
We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.
Interventions
All patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI.
Sponsors
Study design
Eligibility
Inclusion criteria
* pathologically proved rectal cancer * locally advanced rectal cancer (≥T3 or N+) * a distance less than 12cm between the lower edge of tumor and the anal margin * no evidence of distant metastases * no prior anti-cancer therapy before treatment * scheduled to receive preoperative CRT
Exclusion criteria
* history or concurrent of other malignancy * incomplete preoperative CRT * failed to receive surgery or unavailable pCR assessment * poor quality of MR images for measurement * patient quit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response(pCR) | within one week after surgery | Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes. |
Countries
China