Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT02278653|
Recruitment Status : Active, not recruiting
First Posted : October 30, 2014
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment|
|Rectal Neoplasms||Other: Questionnaires for the evaluation of Quality of Life Other: Manometry|
Rectal cancer is a common form of cancer. Standard treatment for locally advanced rectal cancer is a long course of neoadjuvant radiation combined with chemotherapy (CRT) followed by resection. However, neoadjuvant CRT induces downsizing and downstaging, resulting in a complete response in 15-20% of the patients. In these patients surgery may be omitted. In the investigators previous study the investigators obtained good results with an organ saving treatment. Although the mortality and morbidity associated with radical surgery is avoided, the irradiated rectum remains in situ, possibly causing functional problems.
The primary objective is to describe the functional outcome of patients that choose for organ saving treatment. Functional outcome will be evaluated with questionnaires (quality of life) and manometric measurements (maximal resting pressure, maximal squeezing pressure, sphincter length, percentage asymmetry of the resting sphincter, sustained duration, length of the high pressure zone, rectoanal inhibitory reflex, rectal sensory threshold, and rectal compliance).
Secondary objectives include: the estimation of the cumulative risk of local failure within 5 years, the estimation of the cumulative risk of disease-free, distant-metastasis-free and overall survival within 5 years, determine the percentage of patients that chooses organ saving treatment instead of standard resection, determine the compliance to intensive follow-up, and compare the cost-effectiveness of organ saving treatment to standard surgical resection over a period of 5 years. These objectives will be assessed by frequent revision of the electronic patient file, as the patient is followed up to four times per year.
Study design: prospective observational registration study with 'invasive diagnostic procedures' Study population: The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0).
Main study parameters/endpoints: The main study endpoint is the functional outcome scores based on questionnaires and manometric measurements Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The questionnaires take approximately 20 minutes to complete. There is a relatively low rate of side effects associated with manometric measurements. Results of this study will contribute to better understanding of functional complaints after rectal cancer treatment.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Follow up and Functional Outcome of Organ Saving Treatment in Patients With Good Response to Neo-adjuvant (Chemo)Radiation for Rectal Cancer|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||September 2022|
The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0).
Other: Questionnaires for the evaluation of Quality of Life
Manometry is a tool to measure the anal sphincter function. Patients do not need any bowel preparation before this procedure. During the examination a catheter tip will be positioned in the rectum above the sphincter and a small balloon will be inflated. This balloon is connected to a device that registers the measurements. Patients will receive instructions; e.g. squeeze, push, and cough. The procedure takes approximately 10 minutes and is not experienced as painful. Several parameters will be measured: the mean basal pressure, the maximum squeeze pressure, first sensation, first urge to defecate and the maximum tolerable volume. The manometric measurement will take place on the same day as the endoscopy and MRI (standard follow-up).
- Functional outcome [ Time Frame: 5 years ]
Functional outcome scores of patients that are treated with an organ saving strategy compared to patients who undergo the standard resection as described in literature.
Functional outcome will be evaluated with the following questionnaires:
- European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score
- Short Form (36) health survey
- EORTC CR38
- Vaizey score
- Low Anterior Resection Syndrome (LARS) score
- International Index of Erectile Function for men
- International Prostate Symptom Score for men
- Female Sexual Function Index for women
Functional outcome will be measured by manometric measurements:
- mean basal pressure (mmH2O)
- maximum squeeze pressure (mmH2O)
- first sensation (mL)
- first urge to defecate (mL)
- maximum tolerable volume (mL)
- Cumulative risk of local failure [ Time Frame: 5 years ]All patients with a local recurrence will be excluded form further follow-up. This information will be based on an MRI of the lower abdomen in combination with endoscopy.
- Cumulative risks of disease-free, distant-metastasis free and overall survival [ Time Frame: 5 years ]
- The percentage of patients that choose the alternative strategies instead of traditional strategies and the motivation for their choice [ Time Frame: 3 years ]
- The compliance to the intensive follow-up schedule [ Time Frame: 5 years ]All patients are intended to participate in the standard follow-up schedule. Some of them may drop out due to other illness, ageing or other reasons. These patients will be included in the analysis as far as they participated.
- Early detection of local failure (standard surgery still possible) [ Time Frame: 5 years ]In the first year, every three months an MRI of the lower abdomen is made in combination with an endoscopy. From the second to the fifth year, these investigations will be done twice a year. With these short intervals, it is know that local recurence is detected in an early fase.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278653
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Geerard L Beets, MD, PhD||Surgery, MUMC+|
|Study Chair:||Rianne CJ Beckers, MD, MSc||Surgery/Radiology MUMC+|
|Study Chair:||Miriam M van Heeswijk, MD, MSc||Surgery/Radiology MUMC+|
|Study Chair:||Monique Maas, MD, PhD||Radiology, MUMC+|