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Complete Pathologic Response Rectal Cancers

NCT03351959 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2018-05-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

neo-adjuvant treatment

long-course radio-chemoradiation; short-course radiation with immediate/delayed surgery

Sponsors & Collaborators

  • European Society of Surgical Oncology

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Laura Lorenzon · Fondazione Policlinico Universitario A. Gemelli

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2018-06-01
Completion
2018-09-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03351959 on ClinicalTrials.gov