Clinical trial • Phase II/III • Oncology
CAPECITABINE for Locally advanced rectal cancer (stage II/III)
Phase II/III trial of CAPECITABINE for Locally advanced rectal cancer (stage II/III).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Locally advanced rectal cancer (stage II/III)
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 29-11-2024
- First CTIS Authorization Date
- 10-01-2025
Trial design
Randomised, open-label, oxaliplatin (intravenous; product record: oxaliplatin; max daily dose amount listed as 130 mg/m2) and capecitabine (oral; product record: capecitabine; max daily dose amount listed as 2000 mg). specific schedules not specified in ctis record.-controlled Phase II/III trial across 29 sites in Italy.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Oxaliplatin (intravenous; product record: OXALIPLATIN; max daily dose amount listed as 130 mg/m2) and Capecitabine (oral; product record: CAPECITABINE; max daily dose amount listed as 2000 mg). Specific schedules not specified in CTIS record.
- Target Sample Size
- 340
Eligibility
Recruits 340 Vulnerable population selected in CTIS record. Subject information and informed consent forms are listed in the documents (e.g. 'Informativa e consenso NeoAspMet vers 1 del 29 06 2020', 'Consenso tratt dati pers NeoAspMet vers 1 del 7 10 2024 for publication'). No further specific consent/assent handling details provided in the CTIS data..
- Vulnerable Population
- Vulnerable population selected in CTIS record. Subject information and informed consent forms are listed in the documents (e.g. 'Informativa e consenso NeoAspMet vers 1 del 29 06 2020', 'Consenso tratt dati pers NeoAspMet vers 1 del 7 10 2024 for publication'). No further specific consent/assent handling details provided in the CTIS data.
Inclusion criteria
- {"criterion_text":"- 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). For further information please refer to the protocol"}
Exclusion criteria
- {"criterion_text":"- 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. For further information please see protocol"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Good Pathological Response (GPR) defined as Tumour downstaging (ypT0 or ypT1) irrespective of the pathological N stage","definition_or_measurement_approach":"Good Pathological Response (GPR) defined as Tumour downstaging (ypT0 or ypT1) irrespective of the pathological N stage"}
Secondary endpoints
- {"endpoint_text":"- Tumor Regression Rate\n- Pathological complete responses (pCR)\n- NeoAdjuvant Rectal (NAR) score\n- MRI Tumor Downstaging (mr TGR) rate\n- Event-Free Survival (EFS)\n- Overall Survival (OS)\n- Time to Distant Recurrence (TDR)\n- Rate of local recurrence at 3 years\n- Abdominal Perineal Resection (APR) rate\n- Organ preservation rate at 3 years\n- Post-operative complications\n- Treatment-related toxicity\n- Quality of Life (QoL)","definition_or_measurement_approach":"For further information please see protocol"}
Recruitment
- Planned Sample Size
- 340
- Recruitment Window Months
- 70
- Consent Approach
- Subject information and informed consent forms available (document titles in CTIS: 'Informativa e consenso NeoAspMet vers 1 del 29 06 2020', 'Consenso tratt dati pers NeoAspMet vers 1 del 7 10 2024 for publication', 'Lettera medico di base NeoAspMet vers 1 del 29 06 2020'). No further details on who provides consent, age-specific documents or languages are provided in the CTIS data.
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 340
Italy
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 415
- Number Of Sites
- 29
- Number Of Participants
- 340
Sites
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- SCDU Chirurgia Generale
- Contact Person Name
- Maurizio Degiuli
- Contact Person Email
- chirurgia.generale@sanluigi.piemonte.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- SOC Oncologia Medica e Prevenzione Oncologica
- Contact Person Name
- Angela Buonadonna
- Contact Person Email
- abuonadonna@cro.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- UOC Oncologia Chirurgica Colorettale
- Contact Person Name
- Paolo Del Rio
- Contact Person Email
- p.delrio@istitutotumori.na.it
- Site Name
- Casa Di Cura Macchiarella S.p.A.
- Department Name
- Oncologia Medica
- Contact Person Name
- Concetta Maria Porretto
- Contact Person Email
- 69cp@libero.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Oncologia Medica, A.U.S.L. di Reggio Emilia - IRCCS - Presidio Arcispedale S. Maria Nuova
- Contact Person Name
- Maria Banzi
- Contact Person Email
- maria.banzi@ausl.re.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- U. O. di Oncologia Medica 1
- Contact Person Name
- Sara Lonardi
- Contact Person Email
- sara.lonardi@iov.veneto.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Chirurgia gastro-enterologica
- Contact Person Name
- Ugo Elmore
- Contact Person Email
- elmore.ugo@hsr.it
- Site Name
- Sant Andrea Hospital
- Department Name
- Oncologia
- Contact Person Name
- carlo Aschele
- Contact Person Email
- carlo.aschele@asl5.liguria.it
- Site Name
- Azienda Ospedaliera Regionale San Carlo
- Department Name
- Unità Operativa di Oncologia Medica - Azienda Ospedaliera S.Carlo
- Contact Person Name
- Domenico Bilancia
- Contact Person Email
- domenicobilancia@gmail.com
- Site Name
- Azienda Socio Sanitaria Territoriale Di Bergamo Ovest
- Department Name
- U.O. Oncologia Medica Osp. Treviglio
- Contact Person Name
- Petrelli Fausto
- Contact Person Email
- faustopetrelli@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UO Chirurgia tratto alimentare e urgenza
- Contact Person Name
- Gilberto Poggioli
- Contact Person Email
- cuicchidajana@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- Oncologia Medica -AOU Cagliari - Policlinico Universitario "Duilio Casula Monserrato"
- Contact Person Name
- Mario Scartozzi
- Contact Person Email
- marioscartozzi@gmail.com
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Oncologia Medica
- Contact Person Name
- Alessandro Guidi
- Contact Person Email
- alessandro.guidi@asst-monza.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- SSD DH Oncologico Policlinico di Modena -AOU Modena
- Contact Person Name
- Fabio Gelsomino
- Contact Person Email
- gelsomino.fabio@aou.mo.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Oncologia Medica IRCCS Ca' Granda Osp. Maggiore
- Contact Person Name
- Angela Damato
- Contact Person Email
- angela.damato@policlinico.mi.it
- Site Name
- Ospedale San Giovanni Bosco
- Department Name
- SC Oncologia Medica
- Contact Person Name
- Cristiano Oliva
- Contact Person Email
- cristiano.oliva@gmail.com
- Site Name
- Ospedale Isola Tiberina Gemelli Isola
- Department Name
- UOC di Oncologia
- Contact Person Name
- Domenico Cristiano Corsi
- Contact Person Email
- domenico.corsi@libero.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- SCDU Oncologia - AOU Maggiore della Carità - Novara
- Contact Person Name
- Alessandra Gennari
- Contact Person Email
- alessandra.gennari@uniupo.it
- Site Name
- Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario
- Department Name
- Oncologia Medica - Ospedale di Sondrio
- Contact Person Name
- Alessandro Bertolini
- Contact Person Email
- alessandro.bertolini@asst-val.it
- Site Name
- Ospedale Santa Maria della Misericordia
- Department Name
- Dipartimento di Oncologia - ASU FC S. Maria della Misericordia -Udine
- Contact Person Name
- Nicoletta Pella
- Contact Person Email
- nicoletta.pella@asufc.sanita.fvg.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Servizio di Radioterapia Oncologica Gemelli
- Contact Person Name
- Maria Antonietta Gambacorta
- Contact Person Email
- mariaantonietta.gambacorta@policlinicogemelli.it
- Site Name
- Ospedale San Vincenzo Taormina
- Department Name
- Oncologia Medica
- Contact Person Name
- Francesco Ferrau'
- Contact Person Email
- ferrau@oncologiataormina.it
- Site Name
- Azienda Sanitaria Locale Della Provincia Di Biella
- Department Name
- SC Oncologia
- Contact Person Name
- Myriam Katja Paris
- Contact Person Email
- myriamkatja.paris@aslbi.piemonte.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Tumori ereditari dell'apparato digerente
- Contact Person Name
- Marco Vitellaro
- Contact Person Email
- marco.vitellaro@istitutotumori.mi.it
- Site Name
- Istituto Tumori Bari Giovanni Paolo II
- Department Name
- Chirurgia Generale
- Contact Person Name
- Raffaele De Luca
- Contact Person Email
- dr.raffaele.deluca@gmail.com
- Site Name
- Azienda Sanitaria Locale TO3
- Department Name
- Chirugia Generale Ospedale Agnelli
- Contact Person Name
- Andrea Muratore
- Contact Person Email
- amuratore67@gmail.com
- Site Name
- Ospedale ' Civile Maria Paterno' Arezzo
- Department Name
- Oncologia Medica P.O. Maria Paternò Arezzo dell’ASP di Ragusa
- Contact Person Name
- Stefano Cordio
- Contact Person Email
- stefano.cordio@asp.rg.it
- Site Name
- Ospedale S G Moscati
- Department Name
- Oncologia
- Contact Person Name
- Salvatore Pisconti
- Contact Person Email
- salvatore.pisconti@asl.taranto.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale (SSD Chirurgia robotica addominale)
- Department Name
- SSD Chirurgia robotica addominale_
- Contact Person Name
- Ugo Pace
- Contact Person Email
- u.pace@istitutotumori.na.it
Sponsor
Primary sponsor
- Full Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- CAPECITABINE
- Active Substance
- CAPECITABINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 2000 mg (maxDailyDoseAmount)
- Investigational Product Name
- METFORMIN
- Active Substance
- METFORMIN EMBONATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 1700 mg (maxDailyDoseAmount)
- Investigational Product Name
- ACETYLSALICYLIC ACID (CARBASALATE CALCIUM)
- Active Substance
- CARBASALATE CALCIUM
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 100 mg (maxDailyDoseAmount)
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Maximum Dose
- 130 mg/m2 (maxDailyDoseAmount)
- Combination Treatment
- Yes
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