Radiotherapy & Total Neoadjuvant Therapy for Recurrent Rectal Cancer in Previously Irradia
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
| Condition(s) | Rectal Neoplasm |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 irradi |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Locations | Rome, Italy |
| Start date | 2023-06-21 |
| NCT ID | NCT05984576 |
| Official listing | https://clinicaltrials.gov/study/NCT05984576 |