Transanal Endoscopic Microsurgery (TEM) After Radiochemotherapy for Rectal Cancer

NCT ID: NCT01273051

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-08-31

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.

Conditions

Rectal Tumour

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Capecitabine

Capecitabine will be administered at a dose of 825 mg/m2 bid during radiotherapy treatment

Intervention Type: DRUG

radiotherapy

radiation 25x2 Gy

Intervention Type: RADIATION

TME resection

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.

Intervention Type: PROCEDURE

TEM surgery

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients (aged >18 years) with histological proven adenocarcinoma of the distal part of the rectum (below 10 cm) without signs of distant metastases.
• T1-3 tumour without lymph nodes > 5 mm at CT, MRI and endoanal ultrasound.
• ANC > 1.5 x 109/l.
• Thrombocytes > 100 x 109/l.
• Creatinin clearance >50ml/min (according to the Cockcroft-Gault formula)
• Total serum bilirubin < 24 mol/l or below <1.5 times the upper limit of the normal.
• ASAT,ALAT: up to 5 times the upper limit.
• Colonoscopy, colonography or virtual colonoscopy should exclude synchronous colorectal lesions in other parts of the colon.
• ECOG performance score 0-2.
• Fertile women should have adequate birth control during treatment.
• Mental/physical/geographical ability to undergo treatment and follow-up.
• Written informed consent (Dutch language).

Exclusion Criteria

• Patients with Grade 1-2 T1 tumors (can be treated with TEM surgery without chemoradiation therapy)
• Patients with circular rectal tumor or tumors who are by other means unacceptable for TEM surgery (e.g. intra anal tumors).
• Patients with faecal incontinence prior to the diagnosis of rectal cancer (complaints of soiling due to the tumor will not be an exclusion criterium).
• Severe uncontrollable medical or neurological disease.
• Patients with secondary prognosis determining malignancies.
• Patients who have been treated with radiotherapy on the pelvis.
• Use of Vitamin K antagonists.
• Fenytoine and Allopurinol use.
• Known DPD deficiency
• Uncontrolled active infection, compromised immune status, psychosis, or CNS disease.
• Pregnant or lactating women.
• Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months prior to randomisation), myocardial infarction (≤ 6 months prior to randomisation), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
• Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Capecitabine or patients at high risk for treatment complications. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J.H.W de Wilt, Md PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Nijmegen

Locations

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

Erasmus Medical Center

Rotterdam, , Netherlands

Instituut Verbeeten

Tilburg, , Netherlands

Diakonessenhuis

Utrecht, , Netherlands

Countries

Netherlands

References

Bokkerink GM, de Graaf EJ, Punt CJ, Nagtegaal ID, Rutten H, Nuyttens JJ, van Meerten E, Doornebosch PG, Tanis PJ, Derksen EJ, Dwarkasing RS, Marijnen CA, Cats A, Tollenaar RA, de Hingh IH, Rutten HJ, van der Schelling GP, Ten Tije AJ, Leijtens JW, Lammering G, Beets GL, Aufenacker TJ, Pronk A, Manusama ER, Hoff C, Bremers AJ, Verhoef C, de Wilt JH. The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery. BMC Surg. 2011 Dec 15;11:34. doi: 10.1186/1471-2482-11-34.

Reference Type: DERIVED

PMID: 22171697 (View on PubMed)

Other Identifiers

CMO 2010_121

Identifier Type: -

Identifier Source: org_study_id