Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer

September 17, 2019 updated by: Maastricht University Medical Center

Follow up and Functional Outcome of Organ Saving Treatment in Patients With Good Response to Neo-adjuvant (Chemo)Radiation for Rectal Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
Cumulative risks of disease-free, distant-metastasis free and overall survival
Time Frame: 5 years
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
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.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Dutch Cancer Society

Investigators

  • 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+

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL49171.068.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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