The aim of this clinical study is to increase the rate of pathological responses up to 70% by means of improved patient selection operated by a radiobiological index called ERI\_TCP and by an increase in the dose of radiotherapy in the final concomitant boost of preoperative radiochemotherapy treatment for rectal adenocarcinoma.
Histologically confirmed rectal adenocarcinoma
Microsatellite status: stable
Stage T2N0 if lower rectal lesions are candidates for subsequent intersphincteric resection or abdominoperineal amputation with permanent colostomy
Stage T3-T4N0 or any T with positive lymph nodes
Distant metastases
Previous cancer excluding non-melanoma skin cancer diagnosed less than 5 years before rectal cancer appearance
Previous chemotherapy or radiotherapy to the pelvis
Contraindications to radiotherapy: active ulcerative colitis
Single group
Preoperative, adaptive radiotherapy
RadiationPreoperative radiotherapy will consist of 18 fractions to the mesorectum and regional lymph nodes. Halfway through the radiotherapy treatment, patients will undergo a second simulation MRI scan, from which a radiomic index called ERI\_TCP will be calculated: ERI\_TCP=-ln\[(1-(Vmid/Vpre)\]Vpre where Vpre is the volume of the rectal tumor pre-therapy, Vmid is the volume of the residual tumor still visible in the MR images intermediate to RT. This index is able to discriminate patients with a good probability of pathologic complete response (ERI\_TCP\<32.6) and exclude patients with zero probability of pathologic complete response (ERI\_TCP\>32.6). Patients with a good probability of response (41% in our experience) will receive a simultaneous boost delivered in the last 6 fractions to the residual tumor still visible in the intermediate MRI images (adaptive RT). Concomitant chemotherapy consists of Oxaliplatin 85 mg/m2 delivered on days -14, 0, +14, and Capecitabine 825 mg/m2 twice daily or les
Pathological complete response rate
Change the rate of pathological complete responses (pCR) from the present 41% to 70% in the population of patients with ERITCP\<32.6.
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