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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)

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ClinicalTrials.gov Identifier: NCT05984576
Recruitment Status : Recruiting
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
GAMBACORTA MARIA ANTONIETTA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
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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.


Condition or disease Intervention/treatment
Rectal Neoplasm Radiation: Reirradiation

Study Design
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Study Type : Observational
Estimated Enrollment : 88 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : June 21, 2023
Estimated Primary Completion Date : June 5, 2026
Estimated Study Completion Date : June 5, 2031
Groups and Cohorts
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Intervention Details:
  • Radiation: Reirradiation
    Reirradiation recurrent rectal cancer

Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recurrent rectal cancer previously irradiated
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984576


Locations
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Italy
Fondazione Policlinico Gemelli Recruiting
Rome, Italy, 00168
Contact: Maria Antonietta Gambacorta, Prof    0630157894    radioterapia@policlinicogemelli.it   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
More Information
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Responsible Party: GAMBACORTA MARIA ANTONIETTA, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT05984576    
Other Study ID Numbers: 5579
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GAMBACORTA MARIA ANTONIETTA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Radiotherapy
Reirradiation
Recurrent Rectal Cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases