Clinical trial NCT00297141: Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Preoperative
Radiochemotherapy
Newly Diagnosed
Primary Operable
Locally Advanced
Rectal Carcinoma
T3
Lower Rectum
Middle Rectum
ABCSG
TAKO
95
05
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
Collaborators: name: Sanofi-Synthelabo
name: Hoffmann-La Roche
First posted: 2006-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of T-downstaging (Reduction of the T-stadium)
timeFrame: at the time of final surgery
Secondary outcomes:
measure: Evaluation of the toxicity grade III and IV of the therapy scheme
timeFrame: week 1 to max. week 10
Other outcomes:
Locations:
city: St. Veit a. d. Glan
country: Austria
facility: Hospital BHB St. Veit/Glan, Surgery
state: Carinthia
city: Wiener Neustadt
country: Austria
facility: Hospital Wiener Neustadt
state: Lower Austria
city: Graz
country: Austria
facility: Medical University of Graz, Oncology
state: Styria
city: Leoben
country: Austria
facility: State Hospital Leoben, Surgery
state: Styria
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, Surgery
state: Tyrol
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: Upper Austria
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg - Oncology
city: Vienna
country: Austria
facility: Medical University of Vienna, Radiotherapy
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Dietmar Oefner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Alexander de Vries, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Josef Thaler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.