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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

Tracking Information
First Submitted Date May 26, 2023
First Posted Date August 9, 2023
Last Update Posted Date August 9, 2023
Actual Study Start Date June 21, 2023
Estimated Primary Completion Date June 5, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 2, 2023)		 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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
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 Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Recurrent rectal cancer previously irradiated
Condition Rectal Neoplasm
Intervention Radiation: Reirradiation
Reirradiation recurrent rectal cancer
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 2, 2023)		 88
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 5, 2031
Estimated Primary Completion Date June 5, 2026   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT05984576
Other Study ID Numbers 5579
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party GAMBACORTA MARIA ANTONIETTA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Original Responsible Party Same as current
Current Study Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verification Date August 2023