Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297141
• Other study ID #: ABCSG 95 / TAKO 05
• Secondary ID: Studie R02 (95)2
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2006
• Last updated: December 30, 2013
• Start date: October 2004
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 disorders

• 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

Study Design

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

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Drug:
• Capecitabine
chemotherapy oral use
• Oxaliplatin
chemotherapy intravenous use

Locations

Country	Name	City	State
Austria	Medical University of Graz, Oncology	Graz	Styria
Austria	Medical University of Innsbruck, Surgery	Innsbruck	Tyrol
Austria	State Hospital Leoben, Surgery	Leoben	Styria
Austria	Paracelsus Medical University Salzburg - Oncology	Salzburg
Austria	Hospital BHB St. Veit/Glan, Surgery	St. Veit a. d. Glan	Carinthia
Austria	Medical University of Vienna, Radiotherapy	Vienna
Austria	Klinikum Wels-Grieskirchen GmbH	Wels	Upper Austria
Austria	Hospital Wiener Neustadt	Wiener Neustadt	Lower Austria

Sponsors (3)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group	Hoffmann-La Roche, Sanofi-Synthelabo

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of T-downstaging (Reduction of the T-stadium)	surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)	at the time of final surgery	No
Secondary	Evaluation of the toxicity grade III and IV of the therapy scheme	from Visit 1 till surgery: weekly visits (visit 1 to visit 5) followed by final examination (performed 1 to 2 weeks after visit 5) before surgery followed by hospital admission (performed 1 to 2 weeks after final examination) followed by surgery ((performed 1 to 2 weeks after hospital admission)	week 1 to max. week 10	Yes