Transanal Endoscopic Microsurgery (TEM) After Radiochemotherapy for Rectal Cancer (CARTS)
Recruitment status was: Recruiting
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.
Procedure: TME resection
Procedure: TEM surgery
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CHEMORADIOTHERAPY FOR RECTAL CANCER IN THE DISTAL RECTUM FOLLOWED BY ORGANSPARING TRANSANAL ENDOSCOPIC MICROSURGERY: CARTS Study CApecitabine, Radiotherapy and Tem Surgery. A PHASE II, FEASIBILITY TRIAL|
- Response [ Time Frame: Baseline and 6 weeks after chemoradiation therapy ] [ Designated as safety issue: No ]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.
- Quality of life [ Time Frame: baseline, 6-12-24 and 35 months after surgery ] [ Designated as safety issue: No ]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.
- Local Recurrence [ Time Frame: 36 months, 60 months after surgery last enrolled patient ] [ Designated as safety issue: No ]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.
- Toxicity [ Time Frame: 4 weeks after surgery last enrolled patient ] [ Designated as safety issue: No ]
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.
- Number of positive lymph nodes in patient who have been treated with classical surgery [ Time Frame: 4 weeks after surgery last enrolled patient ] [ Designated as safety issue: No ]The number of patients with positive lymph nodes after chemo radiation is expected to be less than 20%, this will carefully be monitored.
- The number of sphincter saving procedures [ Time Frame: 4 weeks after surgery last enrolled patient ] [ Designated as safety issue: No ]after organ sparing surgery by classical TEM or after TME surgery:
|Study Start Date:||November 2010|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273051
|University Medical Centre Nijmegen|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Academisch Medisch Centrum|
|Capelle aan de IJssel, Netherlands|
|Eindhoven, Netherlands, 5602 ZA|
|Erasmus Medical Center|
|Tilburg, Netherlands, 5042 SB|
|Principal Investigator:||J.H.W de Wilt, Md PhD||University Medical Centre Nijmegen|