Clinical trial NCT03064646: Organ Preservation in Locally Advanced Rectal Cancer
Official title: ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: LOCALLY ADVANCED RECTAL CANCER
Keywords: ORGAN PRESERVATION
WATCH AND WAIT
TRANSANAL ENDOSCOPIC MICROSURGERY
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario Elche
First posted: 2017-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of organ preservative strategies after neoadjuvant treatment in locally advanced rectal cancer
timeFrame: 5 years
Secondary outcomes:
measure: Local relapse rate
timeFrame: 2 years and 5 years
measure: Distant relapse rate
timeFrame: 2 years and 5 years
measure: Quality of Life in oncological patients
timeFrame: 3 months; 1 year and annually until 5 years
measure: Quality of Life in patient with rectal cancer
timeFrame: 3 months, 1 year and annually until 5 years
Other outcomes:
measure: Percentage of complete and almost complete responses
timeFrame: 8 weeks after neoadjuvant treatment
measure: Disease free survival
timeFrame: 2 years and 5 years
measure: Overall Survival
timeFrame: 2 years and 5 years
measure: Treatment of relapses
timeFrame: 2 years and 5 years
measure: Outcome of relapses
timeFrame: 2 years and 5 years
measure: Colostomy free survival
timeFrame: 2 years and 5 years
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
Study officials:
affiliation: Hospital General Universitario de Elche
name: Javier Gallego, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Elche
name: Javier Gallego, PhD
role: STUDY_DIRECTOR
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