Organ Preservation in Locally Advanced Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Organ Preservation.
- Who it may be relevant to
- Registry conditions: LOCALLY ADVANCED RECTAL CANCER. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER
Overview
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
Interventions
- Other Organ Preservation
Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy
Primary outcome measures
- Percentage of organ preservative strategies after neoadjuvant treatment in locally advanced rectal cancer [Time frame: 5 years]
Secondary outcome measures (4)
- Local relapse rate [Time frame: 2 years and 5 years]
- Distant relapse rate [Time frame: 2 years and 5 years]
- Quality of Life in oncological patients [Time frame: 3 months; 1 year and annually until 5 years]
- Quality of Life in patient with rectal cancer [Time frame: 3 months, 1 year and annually until 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital General Universitario de Elche — Elche
Identifiers
NCT: NCT03064646 · PRONAR V1.0: 19DEC2016