The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 questionnaires
(quality of life).
Secondary outcome
* Cumulative risk of local failure within 5 years
* Cumulative risks of disease-free, distant-metastasis free and overall
survival within 5 years
* The percentage of patients that choose the alternative strategies instead of
traditional strategies and the motivation for their choice
* The compliance to the intensive follow-up schedule
* Early detection of local failure (standard surgery still possible)
Background summary
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 our previous study we
obtained good results with an organ saving treatment.
The high proportion of complete and good responders with modern chemoradiation
and the improvement in MR-imaging techniques have stimulated a renewed interest
in organ saving treatment, with a crucial question whether or not the benefits
outweigh the risks. More information is required on both the oncological risk
of local failure and the need for salvage surgery and the functional outcome
after this treatment. Although the mortality and morbidity associated with
radical surgery is avoided (e.g. anastomotic leakage, re-laparotomy, wound and
pelvic infection, chronic wound healing disturbances, abscess, colostomy,
faecal or urinary incontinence, and sexual dysfunction), the irradiated rectum
remains in situ, possibly causing functional problems.
Study objective
The primary objective is to describe the functional outcome of patients that
choose for organ saving treatment.
Study design
The proposed study is a prospective observational registration study with
*invasive diagnostic procedures*. Patients with a clinical very good response
to chemoradiation for rectal cancer are offered organ saving treatment as an
alternative to standard TME surgery as a part of our standard patient care. The
oncological and functional outcome will be assessed by diagnostic procedures
and follow up data as a part of standard patient care, and by additional
quality of life questionnaires at four timepoints (figure 1).
Study burden and risks
Questionnaires take approximately 20-30 minutes to complete.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
*1. > 18 years old
2. Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response :
2A. Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI)
2B. 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
3. Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient
4. Choosing for the organ-saving treatment option (wait&see policy or TEM)
5. Informed consent
Exclusion criteria
1. Unable to understand or read Dutch
2. Unwilling to comply to the questionnaires or manometric measurement.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49171.068.14 |