LOCALLY ADVANCED RECTAL CANCER Clinical Trial
Official title:
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.
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
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