Status:
UNKNOWN
THeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI Guided Radiotherapy
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
Viewray Inc.
Conditions:
Neoadjuvant Chemoradiotherapy
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Neoadjuvant chemoradiation therapy (nCRT) is the standard treatment modality in locally advanced rectal cancer (LARC) and patients achieving complete response to treatment (CR) usually have a better p...
Detailed Description
Neoadjuvant chemoradiation therapy (nCRT) is the standard treatment modality in locally advanced rectal cancer (LARC) and patients achieving complete response to treatment (CR) usually have a better p...
Eligibility Criteria
Inclusion
- Histological proven adenocarcinoma of the rectum cT2-3, N0-2 or cT4 for anal sphincter involvement N0-2a, M0
- No prior radiotherapy in pelvic region;
- Tumour located between 0 and 15 cm above the anal verge;
- Not mesorectal fascia involvement for tumor
- No extramesorectal nodes involvement
- No extramural venous invasion (EMVI)
- No rectal mucinous adenocarcinoma histology
- No contra-indications for MRI
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Age over 18 years
- Adequate hematological function: granulocyte count \> 1500/microl; Hemoglobin level \> 10 g/dl; Platelet count \> 100000/microl; Alanine Aminotransferase/ aspartate aminotransferase (ALT/AST): 7-45 UI/L;
- No other malignancies in the previous history (except skin and initial cervical cancer);
- Absence of important comorbidities: severe cardiac or coagulative disease, moderate or severe; restrictive/obstructive lung deficit, severe cognitive impairment, moderate and severe renal and hepatic impairment.
- Absence of any 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;
- Absence of pregnancy or lactating female patients;
- Written informed consent
Exclusion
- not defined
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04815694
Start Date
March 17 2021
End Date
September 30 2022
Last Update
March 25 2021
Active Locations (1)
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1
Fondazione Policlinico Universitario A.Gemelli IRCCS
Roma, Italy, 00168