Objective of this research is to evaluate whether neo-adjuvant chemo-/radiotherapy in small non-advanced rectal cancers can be used to obtain a complete or near complete remission. In these patients could a complete resection of the rectum as an…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the response of the rectal carcinoma to chemo-/radiotherapy
defined as complete response (no visible disease); partial response (more than
50% reduction of the tumour mass); no response (meaning an increase of the
tumour mass less than 25% or a decrease of the tumour mass less than 50%); or
progressive disease when the tumour mass increase more than 25% of the original
tumour mass.
Secondary outcome
Quality of life. Occurrence of local recurrence. Toxicity. Number of positive
lymphnodes in patients who have been treated with classical surgery. The number
of sphincter saving procedures after organ sparing surgery by TEM or after
classical TME surgery.
Background summary
In the Netherlands approximately 2300 new patients are diagnosed with rectal
cancer each year. Standard treatment for patients with a T2 or T3 rectal cancer
consists of preoperative short course of radiotherapy followed by surgery. In
advanced cases long course of radiotherapy combined with chemotherapy is used
instead of a short cause. In some of these advanced cases a complete remission
is observed after a long course of radio-/chemotherapy. Patients who respond
well to neo-adjuvant treatment carry a better prognosis.
Study objective
Objective of this research is to evaluate whether neo-adjuvant
chemo-/radiotherapy in small non-advanced rectal cancers can be used to obtain
a complete or near complete remission. In these patients could a complete
resection of the rectum as an organ be avoided by treating them with a local
excision with the TEM-technique (Transanal Endoscopic Microsurgery) of the
scar. The advantage for these patients is, that they do not need major
abdominal surgery and in a substantial number of these patients the rectum can
be preserved with a better function of continence.
Study design
Patients ,hich from a technical point of view, could be treated by a TEM
resection are candidate for this study. Regardless of their primary T-stage:
T-stage 1, 2 and 3 may participate. However, T-stage should be evaluated with
both endo-sonographic and MRI imaging techniques. Patients will receive
radio-/chemotherapy for a period of 6 weeks. After a waiting period of 6 weeks
a complete re-staging takes place again consisting of endo-sonography and MRI.
Patients who did not respond well to the neo-adjuvant treatment and still have
a T3 tumour will be treated in a classical way by standard total mesorectal
excision (TME) surgery. All patients in whom the tumour did regress to stage T0
or stage T1 or T2 will be operated by a TEM technique. The reason to include T2
stage patients is that both by endo-sonography or MRI after radio-/chemotherapy
a tendancy for overstaging exist. That is reason to include them for TEM. If,
on final pathology, is seen, that the tumour was completely regressed to T0 or
nearly completely regressed to stage T1 without lymfangio invasion, no further
surgical treatment will take place. All patients who still have a T2 tumour or
more will have to undergo salvage TME surgery.
Intervention
The intervention consists of the use of radio-/chemotherapy for 6 weeks
followed by complete re-staging and a TEM procedure if the patient is suitable
after re-staging.
Study burden and risks
The majority of these patients will be treated with local excision of the scar
of their primary tumor by a TEM procedure in stead of a major abdominal
procedure. Chance of postoperative morbidity and mortality is considerably
reduced. Furthermore, these patient will not require a temporary or permanent
stoma. Only those patients that did not respond well enough to the
radiochemotherapy will have standard TME surgery. These patients, if not
identified after secondary staging, will have undergone a TEM procedure and
still will have to undergo a standard TME procedure as well. For these patients
the definitive procedure will be the same as the one that they would have
undergone if they had not participated in the study
po box 9101
6500HB Nijmegen
NL
po box 9101
6500HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
•Patients (aged >18 years) with histological proven adenocarcinoma of the distal third of the rectum without signs of distant metastases.
•T1-3 tumor without lymph nodes > 5 mm at CT, MRI and endoanal ultrasound.
•ANC > 1.5 x 10g/l.
•Thrombocytes > 100 x 109/l.
•Creatinin clearance >50ml/min (according to the Cockcroft-Gault formule)
•Total serum bilirubin < 24 mmol/l or below <1.5 times the upper limit of the normal.
•ASAT,ALAT: up to 5 times the upper limit.
•Colonoscopy, colonography or virtual colonoscopy should exclude synchronous colorectal lesions in other parts of the colon.
•ECOG performance score 0-2.
•Fertile women should have adequate birthcontrol during treatment.
•Mental/physical/geographical ability to undergo treatment and follow-up.
•Written informed consent (Dutch language).
Exclusion criteria
•Patients with Grade 1-2 T1 tumors (can be treated with TEM surgery without chemoradiation therapy)
•Patients with circular rectal tumor or tumors who are by other means unacceptable for TEM surgery (e.g. intra-analtumors).
•Patients with faecal incontinence prior to the diagnosis of rectal cancer (complaints of soiling due to the tumor will not be an exclusion criterium).
•Severe uncontrollable medical or neurological disease.
•Patients with secondary prognosis determining malignancies.
•Patients who have been treated with radiotherapy on the pelvis.
•Use of Warfarin.
•Uncontrolled active infection, compromised immune status, psychosis, or CNS disease.
•Pregnant or lactating women.
•Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (<= 6 months prior to randomisation), myocardial infarction (<= 6 months prior to randomisation), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
• Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Capecitabine or patients at high risk for treatment complications.
History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy).
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 |
|---|---|
| EudraCT | EUCTR2010-019233-97-NL |
| CCMO | NL28982.091.10 |