NCT03351959 (CORSiCA) is a clinical trial of neo-adjuvant treatment in Rectal Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Who is sponsoring NCT03351959?

NCT03351959 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

What drugs are being tested in NCT03351959?

Interventions in NCT03351959: neo-adjuvant treatment.

What condition does NCT03351959 study?

NCT03351959 studies Rectal Cancer.

Is NCT03351959 still recruiting?

NCT03351959 is currently status unknown. Last updated 16 May 2018.

Last reviewed 2018-05-16 · How we verify

NCT03351959: CORSiCA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Complete Pathologic Response Rectal Cancers

Status unknown Last updated 16 May 2018

What this trial tests

trial testing neo-adjuvant treatment in Rectal Cancer in 1,000 participants. Status unknown.

Timeline

1 January 2018

Primary endpoint
1 June 2018

1 September 2018

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	1 January 2018
Primary completion	1 June 2018
Estimated completion	1 September 2018
Sites	1 location across Italy

Drugs / interventions tested

neo-adjuvant treatment

Conditions studied

Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background. About 20% of rectal cancers who underwent neoadjuvant treatment (neoCHT-RT) achieve a pathological complete response in the surgical specimen(ypT0); however, about 10% of ypT0 present metastatic nodes (N+). Although seldom analyzed, ypT0N+ identification could be crucial in order to tailor treatments. Hypotheses. The two hypotheses to test are if we can identify ypT0N+ and if N+ is an independent prognostic factor. Aim 1. To create a large Database (DB) of ypT0. Aim 2. To compare ypT0N0 vs ypT0N+ with respect of their clinical/radiological/molecular features. Aim 3. To investigate long term results. Preliminary Study. Dr Lorenzon is the PI of an Italian retrospective multicentric study conducted on 260 ypT0 focused on treatment and outcomes. Design. The PI will operate in partnership with the European Society of Surgical Oncology (ESSO). A DB will be used by ESSO-affiliated centres for collecting the clinical, pathological and radiological data of ypT0N0/N+, previously treated (last 5 years) and prospectively enrolled (6 months + 2 years of follow-up); each centre will provide a junior (\<40 yrs) member for data collection and a senior investigator .for data validation; all the analyses will be centralized by the PI. ypT0N0 and ypT0N+ will be compared for the clinical/pathological variables, for the gene expression profiles of pre-neoCHT-RT biopsies (grant requested). Uni-multivariate survival analyses (end-points: OS, DFS, DSS) will be conducted at 2 years of follow-up. Impact. This is the first study aimed to investigate ypT0N+ features; their accurate identification could lead to treat safely thousands of ypT0N0/year with local excisions leaving major surgery for N+ patients. Results will change practice and reduce considerably health-related costs; moreover, the molecular profiles will open new frontiers of research.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

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NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03351959 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Last refreshed: 16 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03351959.

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