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Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study


Phase 2
18 Years
80 Years
Not Enrolling
Both
Rectal Cancer

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Trial Information

Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study


Inclusion Criteria:



- Age: 18-80

- bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In
spite of infiltration of the neighbouring organs the tumor has to be basically
surgically complete resectable

- no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a
rectum carcinoma

- WHO performance status 0-2

- adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes -
not more than 100.000/µl)

- adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not
more than 3.5 x ULN)

- adequate renal function (creatinin - not more than 1.5 mg/dl)

- women of childbearing potential: exclusion of pregnancy (negative urin or serum
pregnancy test)

- willingness of women of childbearing potential and accordingly of potent men to use
approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3
month after conclusion of the study

- life expectancy of at least 3 month

- signed Informed Consent before recruitment

- exclusion of distant metastases at the time of recruitment

Exclusion Criteria:

- former radiotherapy of pelvis or abdomen

- former chemotherapy

- any other kind of malign tumor (except adequate treated skin basalioma or in situ
cervical carcinoma) in the last 5 years

- general contraindication or known hypersensitivity against Cetuximab and/or
Capecitabine

- Non malign disease, if there is a contraindication with radiotherapy or chemotherapy
with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac
insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease,
significant neurological or psychiatric disorders

- florid, serious infections at the time of recruitment

- legally limited contractual capability or evidence of neurological or psychiatric
disease, if it will constrict the patients compliance in the opinion of the
investigator

- evidence of lacking cooperation of the patient

- pregnant or breast feeding women

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma

Outcome Time Frame:

descriptive evaluation

Safety Issue:

Yes

Principal Investigator

Josef Thaler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Austrian Breast & Colorectal Cancer Study Group

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

ABCSG R03 (96) / TAKO 06

NCT ID:

NCT00297128

Start Date:

October 2005

Completion Date:

November 2011

Related Keywords:

  • Rectal Cancer
  • pilot study
  • rectal
  • cancer
  • phase II
  • preoperative
  • chemoradiation
  • capecitabine
  • cetuximab
  • operable
  • T4
  • ABCSG
  • TAKO
  • R03
  • 96
  • 06
  • Rectal Neoplasms

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