RecruitingNCT05984576

Radiotherapy & Total Neoadjuvant Therapy for Recurrent Rectal Cancer in Previously Irradiated Patients, an Italian Association for Radiotherapy and Clinical Oncology (AIRO)-GI Platform: a Multi-centre Prospective Observational Study

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

88 participants

Start Date

Jun 21, 2023

Study Type

OBSERVATIONAL

Conditions

Rectal Neoplasm

Summary

The introduction of neoadjuvant chemoradiation therapy (CRT) and the use of advanced surgical techniques have led to a reduction in mortality and recurrence rates for rectal cancer, the rate of which currently stands at 4-8%. Complete cytoreduction (achieving R0) of local recurrence is the main factor correlating with survival, but surgery can often be very complex because of the change in anatomical planes caused by previous surgery. Reirradiation of the recurrence may increase the rate of optimal resection (R0) and may palliate symptoms in unresectable disease. It is a very complex procedure, because one has to take into account the dose previously received by the organs at risk (OARs) and at the same time be able to deliver an effective dose to the recurrence. However with modern irradiation techniques (VMAT) it is possible to increasingly spare the OARs and deliver adequate doses in this setting as well. Besides radiotherapy with conventional fractionation, other promising options are stereotactic body radiotherapy (SBRT) with and proton (PT) and carbon ion RT (CIRT). Another topic of interest is chemotherapy intensification (CHT): recent studies of concomitant and neoadjuvant chemotherapy (Total Neoadjuvant Therapy) have shown high rates of antitumour response, however even this option should be evaluated with caution, because it must take into account previous cancer treatments received by the patient. Based on the evidence reported in the literature, it is reasonable to assume that treatment of local recurrence of rectal cancer should be multimodal, integrating surgical treatment with CHT and RT, using the different technologies available. To this end, proper stratification of patients is necessary in order to target the appropriate therapy according to the type of recurrence and their clinical condition.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting data on patients with rectal cancer that has come back in the pelvis after prior radiation therapy, and who are receiving a second course of radiation (re-irradiation) combined with total neoadjuvant therapy (TNT) — which is chemotherapy given before surgery. The goal is to understand outcomes and identify predictive factors for this challenging clinical scenario. **You may be eligible if:** - You are 18 or older with pelvic recurrence of rectal cancer confirmed by imaging or biopsy - You previously received pelvic radiation more than 6 months ago - You have potentially curable disease (limited distant spread) - Your blood counts and organ function are adequate - Your life expectancy is more than 24 months **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have significant heart, lung, cognitive, or kidney/liver problems - The previous radiation treatment plan is not available in digital format Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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