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History of Changes for Study: NCT05984576
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 (RETRY)
Latest version (submitted August 2, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 2, 2023 None (earliest Version on record)
Comparison Format:

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Study NCT05984576
Submitted Date:  August 2, 2023 (v1)

Open or close this module Study Identification
Unique Protocol ID: 5579
Brief 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 (RETRY)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2023
Overall Status: Recruiting
Study Start: June 21, 2023
Primary Completion: June 5, 2026 [Anticipated]
Study Completion: June 5, 2031 [Anticipated]
First Submitted: May 26, 2023
First Submitted that
Met QC Criteria:
August 2, 2023
First Posted: August 9, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:
August 2, 2023
Last Update Posted: August 9, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible Party: Principal Investigator
Investigator: GAMBACORTA MARIA ANTONIETTA
Official Title: Professor
Affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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 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.

Detailed Description:
Open or close this module Conditions
Conditions: Rectal Neoplasm
Keywords: Radiotherapy
Reirradiation
Recurrent Rectal Cancer
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Other
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 88 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
Radiation: Reirradiation
Reirradiation recurrent rectal cancer
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Local control
[ Time Frame: 8 years ]

The primary aim of this study is to investigate whether the combination of total neoadjuvant therapy (TNT) with re-RT could lead to a better Local Control rate in Local recurrent rectal cancer patients previously irradiated.
Open or close this module Eligibility
Study Population: Recurrent rectal cancer previously irradiated
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Locations: Italy
Fondazione Policlinico Gemelli
[Recruiting]
Rome, Italy, 00168
Contact:Contact: Maria Antonietta Gambacorta, Prof 0630157894 radioterapia@policlinicogemelli.it
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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