The main objective of the study is to provide short and long term oncological and functional outcome data on organ preserving treatment in good responders after a standard indication for neoadjuvant (chemo)radiation. Additional aims are [1] to set…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
2-year non-regrowth disease-free survival, defined as absence of non-regrowth
local or distant recurrence or death within 2 years of FU.
Secondary outcome
Secondary study endpoints are:
1. Number of fully operational centres who can deliver high quality organ
preserving care in rectal cancer in the Netherlands.
2. 2-year local regrowth rate, defined as the proportion of local regrowth
within 2 years of FU.
3. 2-year local control, defined as absence of local recurrence(unresectable
regrowth, resected with R1, or requiring more extensive than TME surgery) or
death within 2 years of FU.
4. 2-year overall survival, defined as absence of death within 2 years of FU
5. Determination of the optimal follow-up schedule with regard to a balance
between early detection of recurrence and compliance to follow-up
6. National registry of all patients treated according to *wait-and-see* policy
in the Netherlands.
7. Quality of life
Background summary
Standard treatment for patients with locally advanced rectal cancer consists of
a long course of chemoradiation (CRT) followed by surgical resection. Although
the aim of neoadjuvant treatment in these patients is not organ preservation,
but rather to provide improved local control, in 15-20% the tumour disappears
completely. Studies from Maastricht, USA and Brazil have shown that in selected
patients with a clinical complete response after CRT, a *wait-and-see* policy
without any surgery could be a safe alternative with comparable long-term
outcome and better functional outcome compared to patients who had surgery.
Study objective
The main objective of the study is to provide short and long term oncological
and functional outcome data on organ preserving treatment in good responders
after a standard indication for neoadjuvant (chemo)radiation. Additional aims
are [1] to set up a national network with expertise centres in the *wait-
and-see* treatment of rectal cancer [2] to set up a national registry for organ
preservation treatment that will generate more evidence on the management and
oncological outcome of patients evaluated and treated with organ preservation
and [3] to offer through this network to all patients who are considered good
candidates this *wait-and-see* approach using the most up to date tools for
selection and follow-up.
Study design
Multicentre prospective observational cohort study
Study burden and risks
The standard treatment (major surgery) after chemoradiation for rectal cancer
is associated with perioperative morbidity and mortality, and with long term
functional morbidity like urinary and fecal incontinence, sexual dysfunction
and a permanent colostomy. In the majority of patients who participate in the
study, major surgery and the associated morbidity can be avoided.
Although scientifical proof shows "wait-and-see" only comes with a small risk,
with adequate selection and follow up, the exact risk is not yet well
established. If the small oncological risk is confirmed by this study, we may
be able to proceed to implement the "wait-and-see" policy as a treatment option
in daily clinical practice, leading to a higher quality of life for a
substantial number of patients with rectal cancer, without compromising
oncological outcome. Therefore, the benefit-risk ratio for this study is
regarded as favourable
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
1. > 18 years old
2. Patients with primary rectal cancer who underwent CRT and show clinical
complete response: Clinical complete response (ycT0N0) after neo-adjuvant
chemoradiation will be determined clinically (digital rectal examination,
endoscopy) and radiologically (MRI)
3. Patients with a clinical good response with a small residual tumour
(ycT1-2N0) who decline the recommended TME surgery
4. Comprehension of the alternative strategies and the concept of unknown risks
are clear to the patient
5. Choosing for the "Wait-and-See" policy
6. Informed consent
Exclusion criteria
1. Recurrent rectal cancer 2. Unable or unwilling to comply to the intensive
follow-up schedule.
Design
Recruitment
Medical products/devices used
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 | NL58095.031.16 |