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
|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|
|Contact: A. Cats, Md firstname.lastname@example.org|
|Contact: S. Vanhoutvin mailto:email@example.com|
|Principal Investigator: A. Cats, Md|
|Academisch Medisch Centrum||Recruiting|
|Contact: P.J. Tanis, Md|
|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|
|Contact: G. Lammering, Md firstname.lastname@example.org|
|Principal Investigator: G. Lammering, Md|
|Laurentius Ziekenhuis||Not yet recruiting|
|Contact: J. Leijtens, Md [mailto:J.Leijtens@lzr.nl]|
|Principal Investigator: J. Leijtens, Md|
|Erasmus Medical Center||Recruiting|
|Contact: C. Verhoef, Md email@example.com|
|Contact: J.J.M.E. Nuyttens, Md firstname.lastname@example.org|
|Principal Investigator: C. Verhoef, Md|
|Sub-Investigator: J.J.M.E. Nuyttens, Md|
|Tilburg, Netherlands, 5042 SB|
|Contact: T. Rozema, md +31 13 - 594 75 65 email@example.com|
|Principal Investigator: T. Rozema, Md|
|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|