NCT00278694

Brief Summary

Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

10.4 years

First QC Date

January 16, 2006

Last Update Submit

September 28, 2016

Conditions

Rectal Cancer

Keywords

Oxaliplatin, radiation

Outcome Measures

Primary Outcomes (2)

  • Safety profile

    5 years

  • Number of patients obtaining pCR

    5 years

Secondary Outcomes (1)

  • Clinical, radiological and molecular response to treatment

    5 years

Study Arms (1)

Chemoradiation

EXPERIMENTAL

Neoadjuvant chemotherapy and chemoradiation

Drug: OxaliplatinDrug: ChemoradiationDrug: 5-FURadiation: Preoperative chemoradiationProcedure: Pelvic surgeryDrug: Neoadjuvant oxaliplatin

Interventions

OxaliplatinDRUG
Chemoradiation
ChemoradiationDRUG
Chemoradiation
5-FUDRUG
Chemoradiation
Preoperative chemoradiationRADIATION
Chemoradiation
Pelvic surgeryPROCEDURE
Chemoradiation
Neoadjuvant oxaliplatinDRUG
Chemoradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Rectal cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

RRHF

Oslo, 0027, Norway

Location

Related Publications (4)

  • 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.

    PMID: 31122213DERIVED

  • 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.

    PMID: 27461255DERIVED

  • 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.

    PMID: 26205955DERIVED

  • 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.

    PMID: 25624177DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

OxaliplatinChemoradiotherapyFluorouracil

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCombined Modality TherapyTherapeuticsDrug TherapyRadiotherapyUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Georg Høyer, DH

    South region committee for research ethics in Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant medical oncology

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

September 1, 2005

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

NO(1)