Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

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

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

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Oxaliplatin

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Paracelsus Medical University Salzburg - Oncology
  • Vienna, Austria, 1090
    • Medical University of Vienna, Radiotherapy
  • Carinthia
    • St. Veit a. d. Glan, Carinthia, Austria, 9330
      • Hospital BHB St. Veit/Glan, Surgery
  • Lower Austria
    • Wiener Neustadt, Lower Austria, Austria, 2700
      • Hospital Wiener Neustadt
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University of Graz, Oncology
    • Leoben, Styria, Austria, 8700
      • State Hospital Leoben, Surgery
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University of Innsbruck, Surgery
  • Upper Austria
    • Wels, Upper Austria, Austria, 4600
      • Klinikum Wels-Grieskirchen GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single arm (radiochemotherapy); single arm study (capecitabine, oxaliplatin)	Drug: Capecitabine; chemotherapy oral use; Other Names: Xeloda; RO 09-1978; Drug: Oxaliplatin; chemotherapy intravenous use; Other Names: treatment defined only by active substance; (no trade name defined; investigators choice)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Austrian Breast & Colorectal Cancer Study Group
• Collaborators: Hoffmann-La Roche; Sanofi-Synthelabo
• Investigators: Principal Investigator: Josef Thaler, MD, Austrian Breast & Colorectal Cancer Study Group; Principal Investigator: Dietmar Oefner, MD, Austrian Breast & Colorectal Cancer Study Group

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 27, 2006
• First Submitted That Met QC Criteria: February 27, 2006
• First Posted (Estimate): February 28, 2006

Study Record Updates

• Last Update Posted (Estimate): December 31, 2013
• Last Update Submitted That Met QC Criteria: December 30, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Preoperative; Locally Advanced; Newly Diagnosed; Radiochemotherapy; ABCSG; T3; TAKO; Rectal Carcinoma; Primary Operable; Lower Rectum; Middle Rectum; 95; 05
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: ABCSG 95 / TAKO 05; Studie R02 (95) (Other Identifier: ABCSG internal study code); 2004-002358-72 (EudraCT Number)