Organ Preservation in Locally Advanced Rectal Cancer

LOCALLY ADVANCED RECTAL CANCER Clinical Trial

— PRONAR  

Official title:

ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03064646
• Other study ID #: PRONAR V1.0: 19DEC2016
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2017
• Est. completion date: February 2027

Study information

• Verified date: September 2018
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: Javier Gallego, PhD
• Phone: +34966616250
• Email: j.gallegoplazas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2027
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• LOCALLY ADVANCED RECTAL CANCER
• Rectal Neoplasms

Intervention

Other:
• Organ Preservation
Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Elche	Elche	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana	Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Disease free survival	Time without recidive	2 years and 5 years
Other	Overall Survival	Survival time from surgery	2 years and 5 years
Other	Treatment of relapses	Treatment administered in case of relapse	2 years and 5 years
Other	Outcome of relapses	Survival after a relapse	2 years and 5 years
Other	Colostomy free survival	Time without colostomy	2 years and 5 years
Primary	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	Local relapse rate	Occurrence of local relapse in patients with an organ preservation strategy	2 years and 5 years
Secondary	Distant relapse rate	Occurrence of distant relapse in patients with an organ preservation strategy	2 years and 5 years
Secondary	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
Secondary	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