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Rectal TumourPhase 2CARTSNCT01273051

Transanal Endoscopic Microsurgery (TEM) After Radiochemotherapy for Rectal Cancer

A Phase 2 study testing Capecitabine, radiotherapy and TME resection in people with Rectal Tumour, run by Radboud University Medical Center at 13 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Tumour
What is being tested?
Capecitabine, radiotherapy and TME resection
Type of treatment
Surgery or procedure
How many people
55 participants
Where
13 sitesNetherlands
Study dates
Nov 2010to Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Netherlands13 sites

  • Academisch Medisch Centrum

    Amsterdam

  • NKI AVL

    Amsterdam

  • Slotervaart Ziekenhuis

    Amsterdam

  • Amphia Ziekenhuis

    Breda

  • IJsselland Ziekenhuis

    Capelle aan den IJssel

  • Catharina Ziekenhuis

    Eindhoven, 5602 ZA

  • LUMC

    Leiden

  • MAASTRO Clinic

    Maastricht

  • University Medical Centre Nijmegen

    Nijmegen, Gelderland, 6500 HB

  • Laurentius Ziekenhuis

    Roermond

  • Erasmus Medical Center

    Rotterdam

  • Instituut Verbeeten

    Tilburg, 5042 SB

  • Diakonessenhuis

    Utrecht

Other trials in Netherlands

About this study

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

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
Being tested
Capecitabine, radiotherapy, TME resection, TEM surgery
Keywords
Rectal Cancer, Radiochemotherapy, TEM, Organ preservation
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

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

  • radiotherapyRadiation

    radiation 25x2 Gy

  • TME resectionProcedure or surgery

    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 surgeryProcedure or 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response

    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.

    Measured: Baseline and 6 weeks after chemoradiation therapy

Secondary outcomes (5)

  1. Quality of life

    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.

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

  2. Local Recurrence

    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.

    Measured: 36 months, 60 months after surgery last enrolled patient

  3. Toxicity

    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.

    Measured: 4 weeks after surgery last enrolled patient

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

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

    Measured: 4 weeks after surgery last enrolled patient

  5. The number of sphincter saving procedures

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

    Measured: 4 weeks after surgery last enrolled patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionAug 2012
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01273051
Sponsor's protocol ID
CMO 2010_121
Acronym
CARTS
Status last verified
Apr 2017
First submitted
22 Nov 2010
Last updated
14 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22171697

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, radiotherapy and TME resection in people with Rectal Tumour, run by Radboud University Medical Center at 13 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response (time frame: Baseline and 6 weeks after chemoradiation therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01273051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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