Status:
RECRUITING
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
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Rectal Neoplasm
Eligibility:
All Genders
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 5 2031
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05984576
Start Date
June 21 2023
End Date
June 5 2031
Last Update
August 9 2023
Active Locations (1)
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1
Fondazione Policlinico Gemelli
Rome, Italy, 00168