Low and Intermediate Risk OliGometastatic ColoREctal CancEr PatieNts Treated with Stereotactic ABlative Radiotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Sacro Cuore Don Calabria di Negrar

About this trial

This is an experimental study without drug or device, randomized, open-label, non-profit, sponsored by the IRCCS Sacro Cuore Don Calabria Hospital in Negrar, which will take place at the Department of Advanced Oncological Radiotherapy and 18 other Italian centers.

The reason for this research study is to evaluate whether stereotactic radiotherapy treatment (SABR), in addition to the systemic chemotherapy treatment foreseen by clinical practice for low-intermediate risk oligometastatic colorectal cancer, is able to:

* delay possible local recurrence and/or distant polymetastatic progression * improve disease-free survival * reduce side effects in the short and long term

thus inducing an improvement in the quality of life of patients suffering from this type of pathology.

Therefore, as part of this randomized study, before starting first or second line systemic therapy for his tumor, the patient will be randomized to one of the following treatment arms:

* Experimental arm: ablative stereotactic radiotherapy on all sites of oligometastatic disease (from 1 to 3 sites, performed at most within the second cycle of systemic therapy) * Control arm: no ablative stereotactic radiotherapy to sites of oligometastatic disease

The procedure that is intended to be tested in the experimental arm is a stereotactic radiotherapy treatment on oligometastases (up to a maximum of 3 sites), with ablative dosage (effective biological dose \>100 Gy), performed before the start of systemic therapy of I or II line (at most within the second cycle of the same).

It is hoped that the addition of this type of radiotherapy will increase the potential clinical benefit of the treatment in the context of colorectal cancer.

Eligibility criteria

Qualifiers

Age ≥18 years

Histologically confirmed CRC

Low and intermediate risk oligometastatic colorectal cancer with 1 to 3 metastases, candidate to I or II line systemic treatment (Low risk: 1 to 3 metastases and cumulative tumor volume smaller than 10 cm3; Intermediate risk: 1 to 3 metastases and cumulative tumor volume bigger than 10 cm3).

Controlled primary tumor regardless of primary surgery or primary systemic treatment

Disqualifiers

Age < 18 years

Brain metastases

Having more than 3 metastases

Malignant pleural effusion or ascites

Trial design

Treatments tested in this trial

  • SABR

Treatment groups

204 Participants
are divided into 2 treatment groups