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Brief Title: Transanal Endoscopic Microsurgery (TEM) After Radiochemotherapy for Rectal Cancer
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
Study ID: NCT01273051
Brief 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. 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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 de IJssel, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
LUMC, Leiden, , Netherlands
MAASTRO Clinic, Maastricht, , Netherlands
Laurentius Ziekenhuis, Roermond, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Instituut Verbeeten, Tilburg, , Netherlands
Diakonessenhuis, Utrecht, , Netherlands
Name: J.H.W de Wilt, Md PhD
Affiliation: University Medical Centre Nijmegen
Role: PRINCIPAL_INVESTIGATOR