Oxaliplatin and 5-FU Based Preoperative Chemoradiation

NCT ID: NCT00278694

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2016-02-29

Brief Summary

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Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Detailed Description

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Effect of treatment, safety profile and quality of life scorings.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemoradiation

Neoadjuvant chemotherapy and chemoradiation

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

Chemoradiation

Intervention Type DRUG

5-FU

Intervention Type DRUG

Preoperative chemoradiation

Intervention Type RADIATION

Pelvic surgery

Intervention Type PROCEDURE

Neoadjuvant oxaliplatin

Intervention Type DRUG

Interventions

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Oxaliplatin

Intervention Type DRUG

Chemoradiation

Intervention Type DRUG

5-FU

Intervention Type DRUG

Preoperative chemoradiation

Intervention Type RADIATION

Pelvic surgery

Intervention Type PROCEDURE

Neoadjuvant oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Rectal cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Svein Dueland

Senior consultant medical oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg Høyer, DH

Role: STUDY_CHAIR

South region committee for research ethics in Norway

Locations

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RRHF

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 31122213 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27461255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26205955 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25624177 (View on PubMed)

Other Identifiers

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Eudractnr 2005-000024-16

Identifier Type: -

Identifier Source: secondary_id

S-05059

Identifier Type: -

Identifier Source: org_study_id

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