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| Name | Class |
|---|---|
| Hospital General Universitario Elche | OTHER |
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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:
All data will be obtained from patient's medical records
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Organ Preservation | Experimental | The experimental strategy is the omission of radical surgery if complete or almost complete response after neoadjuvant treatment for locally advanced rectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Organ Preservation | Other | Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Gallego, PhD | Contact | +34966616250 | j.gallegoplazas@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Javier Gallego, PhD | Hospital General Universitario de Elche | Principal Investigator |
| Javier Gallego, PhD | Hospital General Universitario de Elche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Recruiting | Elche | Alicante | 03203 | Spain |
It is planned to share global data analysis
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| ID | Term |
|---|---|
| D009926 | Organ Preservation |
| D000067369 | Transanal Endoscopic Microsurgery |
| ID | Term |
|---|---|
| D014021 | Tissue Preservation |
| D011309 | Preservation, Biological |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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|
| 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 |
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 |
| D000067368 |
| Transanal Endoscopic Surgery |
| D057605 | Natural Orifice Endoscopic Surgery |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011351 | Proctoscopy |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008866 | Microsurgery |
| D019060 | Minimally Invasive Surgical Procedures |