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Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum

Phase 2
18 Years
80 Years
Not Enrolling
Rectal Cancer

Thank you

Trial Information

Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum

About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and
middle rectum will be recruited.

The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the
additional administration of a chemotherapy will positively influence the effect of the
therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing
and downstaging (as per literature and by own experience) can be reached with an
preoperative combined radiochemotherapy.

Inclusion Criteria:

- Age: 18 - 80

- Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the
tumor located max. 14 cm of the anal verge)

- According to MRI tumor extensions into the perirectal fat tissue (cT3)

- No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma

- WHO performance status 0 - 2

- Adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not
more than 100.000/ml)

- 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 (for example birth-control pill, loop, condom) during and at
least 3 month after closure of the study

- Life expectancy of at least 3 month

- Signed written Informed Consent before recruitment

- Exclusion of distant metastases at the time of recruitment

Exclusion Criteria:

- Former radio- and/or chemotherapy

- Tumor of the upper rectum

- Any other kind of malign tumor in the last five years (except adequate treated basal
cell carcinoma of the skin, or in situ cervical carcinoma)

- Peripheral Neuropathy (NCI CTC - not higher than Grade 1)

- General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine

- Any other untreated not malign diseases: Cardiac insufficiency, angina pectoris,
hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric

- Florid, serious infection at the time of recruitment

- Legally limited capacity or evidence of a neurological or psychiatric disease, the
investigator is the opinion it will constrict the patients compliance

- Evidence of lacking willingness for cooperation of the patient

- Pregnant or breast feeding women

Type of Study:


Study Design:

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

Outcome Measure:

Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)

Principal Investigator

Dietmar Oefner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Austrian Breast & Colorectal Cancer Study Group


Austria: Federal Ministry for Health and Women

Study ID:

ABCSG 95 / TAKO 05



Start Date:

October 2004

Completion Date:

March 2006

Related Keywords:

  • Rectal Cancer
  • Preoperative
  • Radiochemotherapy
  • Newly Diagnosed
  • Primary Operable
  • Locally Advanced
  • Rectal Carcinoma
  • T3
  • Lower Rectum
  • Middle Rectum
  • TAKO
  • 95
  • 05
  • Carcinoma
  • Rectal Neoplasms