LOCALLY ADVANCED RECTAL CANCER PATIENTS IN STAGE II/III MedDRA version: 20.0 Level: PT Classification code 10062099 Term: Rectal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: METFORMINA
Product Code: [657-24-9]
Pharmaceutical Form: Tablet
CAS Number: 657-24-9
Current Sponsor code: 211-517-8
Concentration unit: mg milligram(s)
Concentration type: up to
Concent
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pathologically proven diagnosis of adenocarcinoma of the rectum by endoscopic biopsy within 56 days prior to randomisation. Locally advanced tumour (defined as TNM Stage II or III) based upon the following minimum diagnostic workup: MRI of the pelvis, contrast-enhanced CT of abdomen and chest. Able to undergo induction chemotherapy, chemoradiotherapy and total mesorectal excision (TME). Distal part of the tumour within 0–12 cm of the anal verge (Note: intraperitoneal rectal cancer are excluded) 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: Prior treatment for LARC (recurrent rectal tumours are excluded) or previous pelvic radiotherapy. Unequivocal evidence of established metastatic disease based on minimum diagnostic workup. Patients with equivocal lesions are eligible. Patients already taking daily aspirin and/or metformin for more than 4 weeks prior to randomisation. Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors and to any of the excipients. Hypersensitivity to metformin or to any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to assess the effect of each of the 3 experimental interventions (aspirin, metformin or both, in combination with neoadjuvant induction chemotherapy (ICT) and preoperative chemoradiation (CRT)) compared to standard neoadjuvant ICT;Secondary Objective: The secondary objectives are to assess the effect of the experimental interventions compared to the standard neoadjuvant treatment with ICT followed by CRT;Primary end point(s): Primary endpoint is Good Pathological Response (GPR) defined as Tumour downstaging (ypT0 or ypT1) irrespective of the pathological N stage;Timepoint(s) of evaluation of this end point: Estimated duration of recruitment: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Tumor Regression Rate • Pathological complete responses (pCR) • NeoAdjuvant Rectal (NAR) score • MRI Tumor Downstaging (mr TGR) rate • Event-Free Survival (EFS) • Overall Survival (OS) • Time to Distant Recurrence (TDR) • Rate of local recurrence at 3 years • Abdominal Perineal Resection (APR) rate • Organ preservation rate at 3 years • Post-operative complications • Treatment-related toxicity • Quality of Life (QoL) • Simplified ESMO class risk shift after induction chemotherapy;Timepoint(s) of evaluation of this end point: Estimated duration of recruitment: 3 years | — |
Countries
Italy
Contacts
Public ContactUnità Sperimentazioni Cliniche
INT, IRCCS, G.Pascale
Outcome results
None listed