Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

NCT ID: NCT00297141

Last Updated: 2013-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2013-12-31

Brief 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

Detailed 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.

Conditions

Rectal Cancer

Keywords

Preoperative; Radiochemotherapy; Newly Diagnosed; Primary Operable; Locally Advanced; Rectal Carcinoma; T3; Lower Rectum; Middle Rectum; ABCSG; TAKO; 95; 05

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm (radiochemotherapy)

single arm study (capecitabine, oxaliplatin)

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

chemotherapy oral use

Oxaliplatin

Intervention Type: DRUG

chemotherapy intravenous use

Interventions

Capecitabine

chemotherapy oral use

Intervention Type: DRUG

Oxaliplatin

chemotherapy intravenous use

Intervention Type: DRUG

Other Intervention Names

Xeloda; RO 09-1978; treatment defined only by active substance; (no trade name defined; investigators choice)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi-Synthelabo

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Austrian Breast & Colorectal Cancer Study Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dietmar Oefner, MD

Role: PRINCIPAL_INVESTIGATOR

Austrian Breast & Colorectal Cancer Study Group

Alexander de Vries, MD

Role: PRINCIPAL_INVESTIGATOR

Austrian Breast & Colorectal Cancer Study Group

Josef Thaler, MD

Role: PRINCIPAL_INVESTIGATOR

Austrian Breast & Colorectal Cancer Study Group

Locations

Hospital BHB St. Veit/Glan, Surgery

Saint Veit A. D. Glan, Carinthia, Austria

Hospital Wiener Neustadt

Wiener Neustadt, Lower Austria, Austria

Paracelsus Medical University Salzburg - Oncology

Salzburg, Salzburg, Austria

Medical University of Graz, Oncology

Graz, Styria, Austria

State Hospital Leoben, Surgery

Leoben, Styria, Austria

Medical University of Innsbruck, Surgery

Innsbruck, Tyrol, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Upper Austria, Austria

Medical University of Vienna, Radiotherapy

Vienna, Vienna, Austria

Countries

Austria

References

Ofner D, Devries AF, Schaberl-Moser R, Greil R, Rabl H, Tschmelitsch J, Zitt M, Kapp KS, Fastner G, Keil F, Eisterer W, Jager R, Offner F, Gnant M, Thaler J; TAKO 05/ABCSG R-02 Trial Investigators. Preoperative oxaliplatin, capecitabine, and external beam radiotherapy in patients with newly diagnosed, primary operable, cT(3)NxM0, low rectal cancer: a phase II study. Strahlenther Onkol. 2011 Feb;187(2):100-7. doi: 10.1007/s00066-010-2182-6. Epub 2011 Jan 21.

Reference Type: DERIVED

PMID: 21267531 (View on PubMed)

Other Identifiers

Studie R02 (95)

Identifier Type: OTHER

Identifier Source: secondary_id

2004-002358-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ABCSG 95 / TAKO 05

Identifier Type: -

Identifier Source: org_study_id