Study of Short-course radiotherapy followed by chemotherapy as treatment pre surgery for locally advanced rectal cancer.

Phase 1

• Conditions: ocally advanced rectal cancer; MedDRA version: 21.0Level: PTClassification code 10038050Term: Rectal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001206-29-IT
• Lead Sponsor: Fondazione GONO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Age 18-70 years;
Histologically proven diagnosis of rectal adenocarcinoma;
Patients with locally advanced rectal cancer defined by the presence of at least one of the following features:
ocN2 (defined as at least 4 positive lymphnodes at pelvic MRI)
ocT4
otumor extending to within 1 mm of or beyond mesorectal fascia (i.e., circumferential radial margin threatened or involved)
ocT3, N1
Distal border of the tumour located between 5 and 12 cm from the anal verge (as measured by pelvic MRI);
Eastern Cooperative Oncology Group Performance Status (ECOG PS) =1;
No evidence of metastatic disease by total body CT-scan;
Tumour amenable to curative resection (including pelvic exenteration);
No history of invasive rectal malignancy, regardless of disease-free interval;
No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer;
No clear involvement of the pelvic side walls by imaging.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion Criteria

Patients with radiological evidence of distant metastases;
Previous pelvic radiation therapy;
Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;
Previous treatment with fluoropyrimidine and/or oxaliplatin and/or irinotecan;
Patient with complete dihydropyrimidine dehydrogenase (DPYD) deficiency (homozygous of the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT);
Partial or total colectomy;
Known hypersensitivity to fluorouracil, oxaliplatin or irinotecan.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to evaluate the rate of complete pathologic response (pCR);Secondary Objective: Secondary objectives of this study are to evaluate:<br>•Safety profile<br>•R0 resection rate<br>•Failure-free survival (FFS)<br>•Overall survival (OS)<br>•Distant relapse<br>•Locoregional failure<br>•Clinical complete response after neoadjuvant treatment<br>•Major pathological response (MPR)<br>•Post-operative morbidity and mortality<br>•Quality of life (QoL)<br>•Rectal Continence;Primary end point(s): The primary endpoint is Pathologic Complete Response (pCR) Rate. pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects, achieving complete histological regression with no available tumor cells yT0N0.;Timepoint(s) of evaluation of this end point: 6 months