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NCT Number: NCT01273051

Transanal Endoscopic Microsurgery (TEM) After Radiochemotherapy for Rectal Cancer

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.

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Key information

Conditions

Rectal Tumour Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Centre Nijmegen, Nijmegen, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Capecitabine

Drug

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

Radiotherapy

Radiation

radiation 25x2 Gy

TME resection

Procedure

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.

TEM surgery

Procedure

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.

Primary outcomes

  1. Response

    Time frame: Baseline and 6 weeks after chemoradiation therapy

    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.

Secondary outcomes

  1. Quality of life

    Time frame: baseline, 6-12-24 and 35 months after surgery

    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.

  2. Local Recurrence

    Time frame: 36 months, 60 months after surgery last enrolled patient

    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.

  3. Toxicity

    Time frame: 4 weeks after surgery last enrolled patient

    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.

  4. Number of positive lymph nodes in patient who have been treated with classical surgery

    Time frame: 4 weeks after surgery last enrolled patient

    The number of patients with positive lymph nodes after chemo radiation is expected to be less than 20%, this will carefully be monitored.

  5. The number of sphincter saving procedures

    Time frame: 4 weeks after surgery last enrolled patient

    after organ sparing surgery by classical TEM or after TME surgery:

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study 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

Acronym: CARTS

Important dates

Study start
2010
Primary completion
2012
Study completion
2015
First posted
Jan 10, 2011
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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