Transanal Endoscopic Microsurgery (TEM) After Radiochemotherapy for Rectal Cancer (CARTS)
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.
|Contact: J.H.W. de Wilt, Md PhD||+31 24 361 73 firstname.lastname@example.org|
|Contact: G.M.J. Bokkerink, md||+31 24 361 73 email@example.com|
|University Medical Centre Nijmegen||Recruiting|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Contact: J.H.W. de Wilt, Md Phd +31 24 361 73 65 firstname.lastname@example.org|
|Contact: G.M.J. Bokkerink, Md +31 24 361 73 65 email@example.com|
|Principal Investigator: J.H.W. de Wilt, Md PhD|
|Sub-Investigator: G.M.J. Bokkerink, Md|
|NKI AVL||Not yet recruiting|
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|Academisch Medisch Centrum||Recruiting|
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|Principal Investigator: P.J. Tanis, Md|
|Slotervaart Ziekenhuis||Not yet recruiting|
|Contact: E.J. Derksen, Md EJ.Derksen@slz.nl|
|Principal Investigator: E.J. Derksen, Md|
|Amphia Ziekenhuis||Not yet recruiting|
|Contact: B.J. ten Tije, dr +31 76 595 5000 AtenTije@amphia.nl|
|Principal Investigator: B.J. ten Tije, dr|
|Capelle aan de IJssel, Netherlands|
|Contact: E.J.R. de Graaf, Md EdGraaf@ysl.nl|
|Principal Investigator: E.J.R. de Graaf, Md|
|Eindhoven, Netherlands, 5602 ZA|
|Contact: I de Hingh, Md +31 40 2399111 Ignace.d.Hingh@catharina-ziekenhuis.nl|
|Principal Investigator: I. de Hingh, Md|
|Contact: C.A.M. Marijnen, Md C.A.M.Marijnen@lumc.nl|
|Principal Investigator: C.A.M. Marijnen, Md|
|Sub-Investigator: R. Tollenaar, Md. Phd|
|MAASTRO Clinic||Not yet recruiting|
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|Contact: J. Leijtens, Md [mailto:J.Leijtens@lzr.nl]|
|Principal Investigator: J. Leijtens, Md|
|Erasmus Medical Center||Recruiting|
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|Contact: J.J.M.E. Nuyttens, Md firstname.lastname@example.org|
|Principal Investigator: C. Verhoef, Md|
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|Tilburg, Netherlands, 5042 SB|
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|Diakonessenhuis||Not yet recruiting|
|Contact: A. Pronk, dr +31 88 250 50 00 APronk@diakhuis.nl|
|Principal Investigator: A. Pronk, dr|
|Principal Investigator:||J.H.W de Wilt, Md PhD||University Medical Centre Nijmegen|