Locally advanced rectal cancer MedDRA version: 21.0 Level: PT Classification code 10038050 Term: Rectal cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Irinotecan
Product Code: [Irinotecan]
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
INN or Proposed INN: IRINOTECAN CLORIDRATO TRIIDRATO
CAS Numb
Sponsors
Fondazione GONO
Eligibility
Sex/Gender
All
Inclusion criteria
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: o cN2 (defined as at least 4 positive lymphnodes at pelvic MRI) o cT4 o tumor extending to within 1 mm of or beyond mesorectal fascia (i.e., circumferential radial margin threatened or involved) o cT3, 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: •Safety profile •R0 resection rate •Failure-free survival (FFS) •Overall survival (OS) •Distant relapse •Locoregional failure •Clinical complete response after neoadjuvant treatment •Major pathological response (MPR) •Post-operative morbidity and mortality •Quality of life (QoL) •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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Failure-free survival (FFS) is defined as the time from enrollment to one of the following events: non-radical surgery (non R0/R1) of the primary tumour, intrapelvic recurrence after R0/1 resection of the primary tumour, distant relapse, second primary tumour or death from any cause, whichever occurred first. The determination of disease progression will be based on investigator-reported measurements. Patients who are alive without having one of the above events at the end of the study will be censored at their last radiological assessment.; Overall Toxicity rate, defined as the percentage of patients, relative to the total of enrolled subjects, who receive radiotherapy and at least one cycle of chemotherapy, experiencing any adverse event, according the RTOGTC during SCRT, and according to National Cancer Institute Common Toxicity Criteria (version 5.0), during the consolidation chemotherapy.; G3-4 Toxicity rate, is defined as the percentage of patients, relative to the total of enrolled subjects, who receive radiotherapy and at least one cycle of chemotherapy, experiencing a specific adverse event of grade 3/4, according the RTOGTC during SCRT, and according to National Cancer Institute Common Toxicity Criteria (version 5.0), during the consolidation chemotherapy.; R0 Resection Rate is defined as the percentage of patients, relative to the total of enrolled subjects, undergoing R0 resection of primary tumour. R0 surgery is defined as microscopically margin-negative resection at the histopatological exam.; Overall Survival (OS) is defined as the time from enrolment to death from any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.; Quality of Life, assessed using the EORTC QLQ-C30, the EORTC QLQ-CR29 and the EuroQol EQ-5D questionnaires, and Rectal Continence, assessed using LARS and St. Mark Continence scores, will be evaluate at specific time-points | — |
Countries
Italy
Contacts
Public ContactSede operativa Pisa
Fondazione GONO
Outcome results
None listed