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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Tumour

Thank you

Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Outcome Description:

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.

Outcome Time Frame:

Baseline and 6 weeks after chemoradiation therapy

Safety Issue:

No

Principal Investigator

J.H.W de Wilt, Md PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Nijmegen

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

CMO 2010_121

NCT ID:

NCT01273051

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Rectal Tumour
  • Rectal Cancer
  • Radiochemotherapy
  • TEM
  • Organ preservation
  • Rectal Neoplasms

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