NCT03064646

Brief Summary

PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal cancer after a complete or almost complete response to neoadjuvant treatment is feasible and safe in our environment. The main objective of this project is to implement the organ preservation strategy in the treatment of rectal cancer in our environment within a clinical study that allows the analysis of its results in terms of survival. The secondary objective is to assess local relapse, distant relapse and quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2017Feb 2027

First Submitted

Initial submission to the registry

February 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

March 10, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

4.9 years

First QC Date

February 16, 2017

Last Update Submit

September 25, 2018

Conditions

LOCALLY ADVANCED RECTAL CANCER

Keywords

ORGAN PRESERVATIONWATCH AND WAITTRANSANAL ENDOSCOPIC MICROSURGERY

Outcome Measures

Primary Outcomes (1)

  • Percentage of organ preservative strategies after neoadjuvant treatment in locally advanced rectal cancer

    Patients with a complete or almost complete response after a neoadjuvant treatment will be offered an organ preservation strategy

    5 years

Secondary Outcomes (4)

  • Local relapse rate

    2 years and 5 years

  • Distant relapse rate

    2 years and 5 years

  • Quality of Life in oncological patients

    3 months; 1 year and annually until 5 years

  • Quality of Life in patient with rectal cancer

    3 months, 1 year and annually until 5 years

Other Outcomes (6)

  • Percentage of complete and almost complete responses

    8 weeks after neoadjuvant treatment

  • Disease free survival

    2 years and 5 years

  • Overall Survival

    2 years and 5 years

  • +3 more other outcomes

Study Arms (1)

Organ Preservation

EXPERIMENTAL

The experimental strategy is the omission of radical surgery if complete or almost complete response after neoadjuvant treatment for locally advanced rectal cancer

Other: Organ Preservation

Interventions

Organ PreservationOTHER

Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy

Also known as: Transanal Endoscopic Microsurgery, Watch and Wait
Organ Preservation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with confirmed histopathological diagnosis of rectal adenocarcinoma.
  • Patients treated with neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapy.
  • Patients with evidence of complete or near complete response criteria after completion of neoadjuvant treatment (approximately 8 weeks later). Response criteria should be based on digital rectal examination, flexible rectoscopy and MRI.

You may not qualify if:

  • Evidence of distant metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

RECRUITING

MeSH Terms

Interventions

Organ PreservationTransanal Endoscopic Microsurgery

Intervention Hierarchy (Ancestors)

Tissue PreservationPreservation, BiologicalTherapeuticsInvestigative TechniquesTransanal Endoscopic SurgeryNatural Orifice Endoscopic SurgeryEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisProctoscopyEndoscopy, GastrointestinalEndoscopy, Digestive SystemDigestive System Surgical ProceduresSurgical Procedures, OperativeMicrosurgeryMinimally Invasive Surgical Procedures

Study Officials

  • Javier Gallego, PhD

    Hospital General Universitario de Elche

    PRINCIPAL INVESTIGATOR

  • Javier Gallego, PhD

    Hospital General Universitario de Elche

    STUDY DIRECTOR

Central Study Contacts

Javier Gallego, PhD

CONTACT

+34966616250j.gallegoplazas@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 27, 2017

Study Start

March 10, 2017

Primary Completion

February 1, 2022

Study Completion (Estimated)

February 1, 2027

Last Updated

September 27, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

It is planned to share global data analysis

Locations

ES(1)