Complete Pathologic Response Rectal Cancers

NCT03351959 | Unknown

• 1 other identifier: FPAG002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Rectal Cancer

Keywords

ypT0

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Any case of death

  24 months

Secondary Outcomes (3)

• Disease Free Survival

  24 months

• Disease Specific Survival

  24 months

• Molecular Profile of N+

  24 months

Study Arms (1)

ypT0 rectal cancers

Rectal cancer patients who underwent neo-adjuvant treatment followed by surgical resection and had a final pathologic diagnosis of absence of residual viable tumoral cells within the rectal wall specimen (pathologic complete response, pCR - ypT0).

Radiation: neo-adjuvant treatment

Interventions

neo-adjuvant treatment RADIATION

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

ypT0 rectal cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Rectal cancer patients who underwent neo-adjuvant treatment followed by surgical resection with a final pathologic diagnosis of absence of residual viable tumoral cells within the rectal wall specimen (pathologic complete response, pCR - ypT0).

You may qualify if:

• Rectal cancer patients who underwent neo-adjuvant treatment followed by surgical resection
• Final pathologic diagnosis of absence of residual viable tumoral cells within the rectal wall specimen (pathologic complete response, pCR - ypT0).

You may not qualify if:

• Patients treated with chemotherapy-only protocols
• Stage IV
• Patients presenting peri-operative mortality (\< 30 days from the surgical procedure)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• European Society of Surgical Oncology: collaborator

Study Sites (1)

Fondazione Policlinico Unversitario Agostino Gemelli

Roma, 00168, Italy

RECRUITING

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MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Laura Lorenzon

  Fondazione Policlinico Universitario A. Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Lorenzon

CONTACT

0630154511; laura.lorenzon@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 24, 2017
• Study Start: January 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 16, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)