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. 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Capecitabine will be administered at a dose of 825 mg/m2 bid during radiotherapy treatment
radiation 25x2 Gy
All patients undergo a MRI of the pelvis and a rectoscopy and endorectal ultrasound 6 weeks after chemo radiation. Patients who do not respond or clinically have a T3 tumour either on visual measurements or post therapy MRI or endoanal ultrasound will be operated on with a TME resection 8 - 10 weeks after the last chemo radiation treatment.
All patients undergo a MRI of the pelvis and a rectoscopy and endorectal ultrasound 6 weeks after chemo radiation.Patients with a significant downsizing of the tumour (T0-T2) will be operated on by TEM surgery 8 -10 weeks after the last chemo radiation treatment. After TEM surgery, pathological assessment will dictate further treatment. Conservative treatment with careful follow-up will be performed in patients with a complete resection of a ypT0-1 rectal tumour. Patients with lymphangio invasion, an incomplete resected ypT1 (\<2 mm margin), an ypT2 or ypT3 tumour after TEM will subsequently undergo TME surgery to remove the rectum within 4 weeks.
University Medical Centre Nijmegen
Nijmegen, Gelderland, Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands
NKI AVL
Amsterdam, Netherlands
Slotervaart Ziekenhuis
Amsterdam, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
LUMC
Leiden, Netherlands
MAASTRO Clinic
Maastricht, Netherlands
Laurentius Ziekenhuis
Roermond, Netherlands
...and 3 more locations
Response
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.
Time frame: Baseline and 6 weeks after chemoradiation therapy
Quality of life
Quality of life form EORTC-QLQC30 and 38. Determine the faecal continence and QOL after treatment with TEM surgery will be compared with TME treated patients.
Time frame: baseline, 6-12-24 and 35 months after surgery
Local Recurrence
Careful follow-up will determine the local recurrence rate of patients treated with TEM and TME surgery. This will be standard colorectal cancer follow-up with additional endo-anal endography and MRI for patients treated with TEM surgery during the first two years.
Time frame: 36 months, 60 months after surgery last enrolled patient
Toxicity
Regional and systemic Toxicity/Side effects will be recorded according to the CTC-Toxicity Grading system, CTC-NCIC Toxicity Criteria v. 3.0. (See appendix to the protocol). Surgical and postoperative complications will be collected and assessed during interim analysis.
Time frame: 4 weeks after surgery last enrolled patient
Number of positive lymph nodes in patient who have been treated with classical surgery
The number of patients with positive lymph nodes after chemo radiation is expected to be less than 20%, this will carefully be monitored.
Time frame: 4 weeks after surgery last enrolled patient
The number of sphincter saving procedures
after organ sparing surgery by classical TEM or after TME surgery:
Time frame: 4 weeks after surgery last enrolled patient
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