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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIRCCS San Raffaele

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Preoperative, adaptive radiotherapy

Treatment groups

33 Participants
are divided into 1 treatment group

Sponsors and collaborators