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Oxaliplatin and 5-FU Based Preoperative Chemoradiation (LARC-RRP)

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Oxaliplatin
Chemoradiation
5-FU
Preoperative chemoradiation
Pelvic surgery
Neoadjuvant oxaliplatin
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Oxaliplatin, radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Rectal cancer

Sites / Locations

  • RRHF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemoradiation

Arm Description

Neoadjuvant chemotherapy and chemoradiation

Outcomes

Primary Outcome Measures

Safety profile
Number of patients obtaining pCR

Secondary Outcome Measures

Clinical, radiological and molecular response to treatment

Full Information

First Posted
January 16, 2006
Last Updated
September 28, 2016
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00278694
Brief Title
Oxaliplatin and 5-FU Based Preoperative Chemoradiation
Acronym
LARC-RRP
Official Title
Oxaliplatin and 5-FU Based Preoperative Chemoradiation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

5. Study Description

Brief Summary
Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.
Detailed Description
Effect of treatment, safety profile and quality of life scorings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Oxaliplatin, radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiation
Arm Type
Experimental
Arm Description
Neoadjuvant chemotherapy and chemoradiation
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Chemoradiation
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Type
Radiation
Intervention Name(s)
Preoperative chemoradiation
Intervention Type
Procedure
Intervention Name(s)
Pelvic surgery
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant oxaliplatin
Primary Outcome Measure Information:
Title
Safety profile
Time Frame
5 years
Title
Number of patients obtaining pCR
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Clinical, radiological and molecular response to treatment
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Rectal cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Høyer, DH
Organizational Affiliation
South region committee for research ethics in Norway
Official's Role
Study Chair
Facility Information:
Facility Name
RRHF
City
Oslo
ZIP/Postal Code
0027
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
31122213
Citation
Abrahamsson H, Porojnicu AC, Lindstrom JC, Dueland S, Flatmark K, Hole KH, Seierstad T, Moan J, Redalen KR, Meltzer S, Ree AH. High level of circulating vitamin D during neoadjuvant therapy may lower risk of metastatic progression in high-risk rectal cancer. BMC Cancer. 2019 May 23;19(1):488. doi: 10.1186/s12885-019-5724-z.
Results Reference
derived
PubMed Identifier
27461255
Citation
Kalanxhi E, Hektoen HH, Meltzer S, Dueland S, Flatmark K, Ree AH. Circulating proteins in response to combined-modality therapy in rectal cancer identified by antibody array screening. BMC Cancer. 2016 Jul 26;16:536. doi: 10.1186/s12885-016-2601-x.
Results Reference
derived
PubMed Identifier
26205955
Citation
Hektoen HH, Flatmark K, Andersson Y, Dueland S, Redalen KR, Ree AH. Early increase in circulating carbonic anhydrase IX during neoadjuvant treatment predicts favourable outcome in locally advanced rectal cancer. BMC Cancer. 2015 Jul 24;15:543. doi: 10.1186/s12885-015-1557-6.
Results Reference
derived
PubMed Identifier
25624177
Citation
Ree AH, Flatmark K, Saelen MG, Folkvord S, Dueland S, Geisler J, Redalen KR. Tumor phosphatidylinositol 3-kinase signaling in therapy resistance and metastatic dissemination of rectal cancer: opportunities for signaling-adapted therapies. Crit Rev Oncol Hematol. 2015 Jul;95(1):114-24. doi: 10.1016/j.critrevonc.2015.01.003. Epub 2015 Jan 12.
Results Reference
derived

Learn more about this trial

Oxaliplatin and 5-FU Based Preoperative Chemoradiation

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