Organ Preservation in Locally Advanced Rectal Cancer (PRONAR)

ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER

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.

Study Overview

• Status: Recruiting
• Conditions: LOCALLY ADVANCED RECTAL CANCER
• Intervention / Treatment: Other: Organ Preservation

Detailed Description

After pathology confirmed rectal cancer patients with stage II and III (MRI, CT and endoscopy) will be identified in the first visit to Medical Oncology Department. Patients will receive the most appropriate neoadjuvant treatment according to clinical guidelines.

Response to neoadjuvant treatment will be assessed by MRI. Those patients with a complete response in MRI, confirmed by endoscopy, will be offered a "watch and wait" strategy. Patients with a complete response in MRI, with an almost complete response in endoscopy, will be offered transanal endoscopic microsurgery. All patients with complete or near complete response will sign an informed consent before study entry.

Radical surgery will be performed in patients without complete or almost complete response criteria after neoadjuvant treatment.

Patients in organ preserving strategy will be subjected to a more intensive follow up schedule, including MRI and endoscopy, compared to patients with radical surgery.

As the complete histopathologic response rate after neoadjuvant treatment in locally advanced rectal cancer is approximately 15-20%, considering that approximately 40 patients with locally advanced rectal cancer are diagnosed annually in our setting, approximately 6-8 patients per year could be potentially recruited for this project, until reaching an initial sample of 30 patients for evaluation.

The following results will be analyzed:

• Percentage of complete and almost complete responses.
• Percentage of watch and wait and transanal endoscopic microsurgery.
• Disease free survival.
• Overall survival.
• Local relapse rate.
• Distant relapse rate.
• Treatment and outcomes of relapses.
• Colostomy free survival.
• Quality of life.

All data will be obtained from patient's medical records

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javier Gallego, PhD; Phone Number: +34966616250; Email: j.gallegoplazas@gmail.com

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Recruiting
      • Hospital General Universitario de Elche
      • Contact: Javier Gallego, PhD; Phone Number: +34966616250; Email: j.gallegoplazas@gmail.com
      • Contact: Silvia Fernández, MS; Phone Number: +966616250; Email: silviafernandezf@gmail.com
      • Sub-Investigator: Antonio Arroyo, PhD
      • Sub-Investigator: Francisco J Sola-Vera, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Evidence of distant metastases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Organ Preservation; 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; Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy; Other Names: Transanal Endoscopic Microsurgery; Watch and Wait

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local relapse rate	Occurrence of local relapse in patients with an organ preservation strategy	2 years and 5 years
Distant relapse rate	Occurrence of distant relapse in patients with an organ preservation strategy	2 years and 5 years
Quality of Life in oncological patients	Assess QLQ-C30 in patients with an organ preservation strategy	3 months; 1 year and annually until 5 years
Quality of Life in patient with rectal cancer	Assess QLQ-CR38 in patients with an organ preservation strategy	3 months, 1 year and annually until 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of complete and almost complete responses	Occurrence of complete and almost complete responses assessed by MRI and confirmed by endoscopy after neoadjuvant treatment	8 weeks after neoadjuvant treatment
Disease free survival	Time without recidive	2 years and 5 years
Overall Survival	Survival time from surgery	2 years and 5 years
Treatment of relapses	Treatment administered in case of relapse	2 years and 5 years
Outcome of relapses	Survival after a relapse	2 years and 5 years
Colostomy free survival	Time without colostomy	2 years and 5 years

Collaborators and Investigators

• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Collaborators: Hospital General Universitario Elche
• Investigators: Study Director: Javier Gallego, PhD, Hospital General Universitario de Elche

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2027

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: TRANSANAL ENDOSCOPIC MICROSURGERY; ORGAN PRESERVATION; WATCH AND WAIT
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: PRONAR V1.0: 19DEC2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is planned to share global data analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No