Actively 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
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2023-08-09
88
Participants Needed
1
Research Sites
415 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 25 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate blood cell counts: granulocytes >1500/bcL, hemoglobin >10 g/dL, platelets >100000/bcL
- Liver enzyme levels (ALT/AST) between 7 and 45 international units per liter
- Potentially curable oligo-metastatic disease
- Life expectancy of more than 24 months
- Pelvic local recurrent rectal cancer confirmed by histology or imaging (MRI, CT, PET)
- Previous pelvic irradiation at least 6 months prior
- Available previous treatment plan in DICOM format
You will not qualify if you...
- Under 18 years old
- Pregnant or breastfeeding women
- Psychological, family, social, or geographic conditions that may interfere with study compliance
- Severe comorbid conditions such as serious heart or clotting disorders, moderate or severe lung disease, severe cognitive impairment, or moderate to severe kidney or liver problems
- Refusal to provide written informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Gemelli
Rome, Italy, 00168
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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