Reirradiation for recurrent rectal cancer in patients who have been previously treated

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

This study is testing if giving radiation treatment again, along with other therapies, can help people with recurring rectal cancer who have already had radiation before.

Quick facts

• Study type: Observational
• Enrollment: 88 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Rome)
• Trial ID: NCT05984576 on ClinicalTrials.gov

What this trial studies

This observational study investigates the effects of reirradiation combined with total neoadjuvant therapy in patients with recurrent rectal cancer who have previously undergone radiation treatment. The study aims to assess the feasibility and outcomes of this approach, focusing on achieving complete cytoreduction and improving patient survival rates. Advanced irradiation techniques will be utilized to minimize damage to surrounding organs while delivering effective doses to the cancerous tissue. The study will involve multiple centers and will collect data on patient responses and surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a history of pelvic irradiation and recurrent rectal cancer that is potentially curable.

Not a fit: Patients under 18 years old, those with contraindications to MRI or CT scans, or those with significant psychological or geographical barriers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and survival rates for patients with recurrent rectal cancer.

How similar studies have performed: While the approach of reirradiation is complex, similar studies have shown promising results in improving outcomes for patients with recurrent cancers.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years old;
* Eastern Cooperative Oncology Group (ECOG) 0-1;
* Adequate hematological function, i.e.:
* Granulocyte count \> 1500/µL;
* Hemoglobin level \>10 g/dL;
* Platelet count \> 100000/µL;
* Alanine aminotransferase (ALT)/aspartate aminotransferase (AST): 7-45 international units (UI)/L.
* Potentially curable Oligo-metastatic disease;
* Life expectancy of more than 24 months;
* Histologically (if feasible) or radiologically MRI (magnetic resonance imaging), if no contraindications, and CT (computed tomography) and/or Positron Emission Tomography scan (PET) proven pelvic local recurrent rectal cancer (LRRC);
* Previous pelvic irradiation \> 6 months;
* Availability of the previous treatment plan in DICOM format only (Digital Imaging and COmmunications in Medicine).

Exclusion Criteria:

* Age \<18 y.o.;
* Pregnancy or lactating female patients;
* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial);
* Important comorbidities (such as: severe cardiac or coagulative disease, moderate or severe restrictive/obstructive lung deficit, severe cognitive impairment, moderate and severe renal and hepatic impairment.
* Refusal to sign written informed consent.

Where this trial is running

Rome

• Fondazione Policlinico Gemelli — Rome, Italy (Recruiting)

Conditions Rectal Neoplasm; Radiotherapy; Reirradiation; Recurrent Rectal Cancer