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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fondazione Policlinico Gemelli
  Rome, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.