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

NCT07580027 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-05-12

No results posted yet for this 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.

Conditions

  • Locally Advanced Rectal Carcinoma

Interventions

RADIATION

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

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Nadia Di Muzio, Professor · Radiation Oncology Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07580027 on ClinicalTrials.gov