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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
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.

Condition or disease Intervention/treatment
Rectal Neoplasms Other: Questionnaires for the evaluation of Quality of Life Other: Manometry

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Study group
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
  1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score
  2. Short Form (36) health survey
  3. EORTC CR38
  4. Vaizey score
  5. Low Anterior Resection Syndrome (LARS) score
  6. International Index of Erectile Function for men
  7. International Prostate Symptom Score for men
  8. Female Sexual Function Index for women

Other: Manometry
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).




Primary Outcome Measures :
  1. 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:

    1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score
    2. Short Form (36) health survey
    3. EORTC CR38
    4. Vaizey score
    5. Low Anterior Resection Syndrome (LARS) score
    6. International Index of Erectile Function for men
    7. International Prostate Symptom Score for men
    8. Female Sexual Function Index for women

    Functional outcome will be measured by manometric measurements:

    1. mean basal pressure (mmH2O)
    2. maximum squeeze pressure (mmH2O)
    3. first sensation (mL)
    4. first urge to defecate (mL)
    5. maximum tolerable volume (mL)


Secondary Outcome Measures :
  1. 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.

  2. Cumulative risks of disease-free, distant-metastasis free and overall survival [ Time Frame: 5 years ]
  3. The percentage of patients that choose the alternative strategies instead of traditional strategies and the motivation for their choice [ Time Frame: 3 years ]
  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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). Patients will be recruited from the outpatient clinic, by researchers or research nurses at Maastricht University Medical Center.
Criteria

Inclusion Criteria:

  • 18 years old
  • Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response :

    • Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI)
    • Very good response (ycT1-2N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI). These patients will undergo a TEM to resect the small residual tumor
  • Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient
  • Choosing for the organ-saving treatment option (wait&see policy or TEM)
  • Informed consent

Exclusion Criteria:

  • Unable to understand or read Dutch
  • Unwilling to comply to the questionnaires or manometric measurement.

Information from the National Library of Medicine

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


Locations
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Netherlands
MUMC+
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Dutch Cancer Society
Investigators
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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+

Additional Information:

Publications:

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02278653    
Other Study ID Numbers: NL49171.068.14
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Keywords provided by Maastricht University Medical Center:
Restaging
Watchful Waiting
Quality of Life
Manometry
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases