Randomized Study on Neoadjuvant Radio-Chemotherapy in Rec... | NCT00309517

Studies
Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C

NCT00309517

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Status

Terminated

Last Update Posted

Apr 3, 2006Estimated

Enrollment

700

Phase

Phase 3

Conditions

Rectal Cancer Dukes B, Dukes C

Interventions

Fluourouracil
Leucovorin
MAb 17-1A

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

Oct 2000

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1997

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 31, 2006

First Submission Date that Met QC Criteria

Mar 31, 2006

First Posted Date

Apr 3, 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

Mar 31, 2006

Last Update Posted Date

Apr 3, 2006Estimated

Description Module

Brief Summary

This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).

Detailed Description

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

700

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically verified operable rectal cancer Dukes B and C (Stage II, T2-4, N0-3, M0), R0
Age: 18-80 years
Karnofsky Performance Status > 80
Adequate bone marrow reserve (leukocytes > 4,000, thrombocytes > 105/mm3, Hb > 10g %), renal and hepatic functions (total bilirubin and creatinine < 1.25 x ULN)

Exclusion Criteria:

Colon cancer
R1, R2; carcinosis peritonei
Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
Previous application of a murine or chimeric monoclonal antibody or antibody fragment
Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months pre-study
Known hypersensitivity to animal protein
Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell. gravis, cerebral seizure disorder, et al.
Pregnancy or lactation

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
Raimund Jakesz, MD	Austrian Breast & Colorectal Cancer Study Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Oberpullendorf		Oberpullendorf	Burgenland	7350	Austria
Hospital Baden

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002955	Leucovorin
C400149	Edrecolomab

Ancestor Terms

ID	Term
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Local recurrence-free survival
Overall survival

Name	Type	Description	Arm Group Labels	Other Names
Fluourouracil	Drug
Leucovorin	Drug
MAb 17-1A	Drug