CClinicalTrials.gg
CompletedNCT00278694LARC-RRPUpdated Sep 29, 2016

Oxaliplatin and 5-FU Based Preoperative Chemoradiation

A Phase 2 interventional study of Oxaliplatin and Chemoradiation in Rectal Cancer, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-29.

Sponsored by Oslo University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
109
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Read the detailed description

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

02

Conditions studied

  • Rectal Cancer

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Keywords

  • Oxaliplatin, radiation
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 109 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Rectal cancer

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
109 participants (actual)

Study arms

  • Experimental
    Chemoradiation

    Neoadjuvant chemotherapy and chemoradiation

    Drug: Oxaliplatin · Drug: Chemoradiation · Drug: 5-FU · Radiation: Preoperative chemoradiation · Procedure: Pelvic surgery · Drug: Neoadjuvant oxaliplatin

Interventions

  • DrugOxaliplatin
  • DrugChemoradiation
  • Drug5-FU
  • RadiationPreoperative chemoradiation
  • ProcedurePelvic surgery
  • DrugNeoadjuvant oxaliplatin
06

What researchers measure

Primary outcomes

  1. Safety profile

    Time frame: 5 years

  2. Number of patients obtaining pCR

    Time frame: 5 years

Secondary outcomes

  1. Clinical, radiological and molecular response to treatment

    Time frame: 5 years

07

Study locations

1 site
  • RRHF
    Oslo, 0027, Norway
08

References and documents

Publications

  • 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. PubMed 31122213 ↗
  • 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. PubMed 27461255 ↗
  • 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. PubMed 26205955 ↗
  • 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. PubMed 25624177 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00278694
Lead sponsor
Oslo University Hospital
Responsible party
Svein Dueland (Senior consultant medical oncology, Oslo University Hospital) — Principal investigator
First posted
Jan 18, 2006
Start date
Sep 2005
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Sep 29, 2016

Study contacts

Georg Høyer, DH
study chair · South region committee for research ethics in Norway
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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