Preoperative, Adaptive Radiotherapy Concomitant to Chemotherapy for Rectal Adenocarcinoma (Adaptive Rectal Cancer Trial 02)

NCT07580027 · tracked via the Priya Life Science Italy tracker

Sponsor

IRCCS San Raffaele

Phase

Not applicable

Started

2026-04-30

Last updated

2026-05-12

Condition(s) studied

Locally Advanced Rectal Carcinoma

Investigational drug(s) / intervention(s)

Preoperative, adaptive radiotherapy

Preoperative, adaptive radiotherapy: Preoperative 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

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: Initial phase (standard phase). These criteria represent the conditions for which preoperative chemoradiotherapy treatment for rectal cancer is clinically indicated 1. Histologically confirmed rectal adenocarcinoma 2. Microsatellite status: stable 3. Stage T2N0 if lower rectal lesions are candidates for subsequent intersphincteric resection or abdominoperineal amputation with permanent colostomy 4. Stage T3-T4N0 or any T with positive lymph nodes 5. Lower margin of lesion no more than 12 cm from anal verge Adaptive radiotherapy phase (experimental phase) 6. ERI\_TCP \< 32.6 calculated as follows: ERITCP=-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 images of the MR intermediate to RT) 7. Lower margin of rectal lesion at least 1 cm from surgical resection line on images of the intermediate smc MRI 8. ECOG (Eastern Cooperative Oncology Group) Performance Status ≤ 2 9. Age: 18-80 years 10. Written informed consent Exclusion Criteria: 1. Distant metastases 2. Previous cancer excluding non-melanoma skin cancer diagnosed less than 5 years before rectal cancer appearance 3. Previous chemotherapy or radiotherapy to the pelvis 4. Contraindications to radiotherapy: active ulcerative colitis 5. Contraindications to chemotherapy: NE\<1.5x10/L, Plt \< 100x10/L), creatinine \>1,5mg/dl, bilirubin \> 2mg/dl, AST/ALT \> 3x normal upper limit, significant cardiac disease, peripheral neuropathy. 6. Pregnancy 7. Breastfeeding

Primary outcome measure(s)

Pathological complete response rate — The time between the end of radiochemotherapy and the availability of the histological examination, on which the complete pathological response is defined, is expected to be 8-10 weeks
Change the rate of pathological complete responses (pCR) from the present 41% to 70% in the population of patients with ERITCP\<32.6.

Trial sites (1)

Facility	City	Region	Status
I.R.C.C.S. San Raffaele Hospital	Milan	Italy

More IRCCS San Raffaele trials in Italy

Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen Recruiting

Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma. Recruiting

Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases Recruiting

Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis Recruiting

Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis Recruiting

Other trials for the same condition

Radiological Markers in Locally Advanced Rectal Cancer Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07580027 on ClinicalTrials.gov ↗ ← All trials in Italy