Preoperative Chemoradiation With Capecitabine and Cetuximab | NCT00297128

Studies
Preoperative Chemoradiation With Capecitabine and Cetuximab

NCT00297128

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Status

Completed

Last Update Posted

Dec 30, 2011Estimated

Enrollment

31Actual

Phase

Phase 2

Conditions

Rectal Cancer

Interventions

Capecitabine
Cetuximab

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Aug 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Feb 27, 2006

First Submission Date that Met QC Criteria

Feb 27, 2006

First Posted Date

Feb 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2011

Last Update Posted Date

Dec 30, 2011Estimated

Name	Class
Hoffmann-La Roche	INDUSTRY
Merck Gesellschaft mbH, Austria	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Capecitabine Drug: Cetuximab

Name	Type	Description	Arm Group Labels	Other Names
Capecitabine	Drug	825 mg/m2 bid (on each therapy day of first 4 therapy weeks)	1

Measure	Description	Time Frame
feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma		descriptive evaluation

Measure	Description	Time Frame
collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status		description evaluation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 18-80
bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable
no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma
WHO performance status 0-2
adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl)
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 (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study
life expectancy of at least 3 month
signed Informed Consent before recruitment
exclusion of distant metastases at the time of recruitment

Exclusion Criteria:

former radiotherapy of pelvis or abdomen
former chemotherapy
any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years
general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine
Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders
florid, serious infections at the time of recruitment
legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator
evidence of lacking cooperation of the patient
pregnant or breast feeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Josef Thaler, MD	Austrian Breast & Colorectal Cancer Study Group	Principal Investigator
Joerg Tschmelitsch, MD	Austrian Breast & Colorectal Cancer Study Group	Principal Investigator
Alexander de Vries, MD	Austrian Breast & Colorectal Cancer Study Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital BHB St. Veit/Glan, Surgery		Saint Veit A. D. Glan	Carinthia	9330	Austria
Hospital Wiener Neustadt, Surgery

ID	Term
D012004	Rectal Neoplasms
D009369	Neoplasms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines