CompletedPhase 2

Transanal Endoscopic Microsurgery (TEM) After Radiochemotherapy for Rectal Cancer

Netherlands55 participantsStarted 2010-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Allopur…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response

Timeframe: Baseline and 6 weeks after chemoradiation therapy

Trial details

NCT IDNCT01273051

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Rectal Tumour trials