NCT01806259

Brief Summary

Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_3

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

February 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

April 7, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

February 20, 2013

Results QC Date

December 5, 2019

Last Update Submit

March 26, 2020

Conditions

Curative Breast Cancer SurgeryInflammatory Positive/Negative StatusPre Surgical Incision Administration

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free Survival

    2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)

    5 years

Other Outcomes (1)

  • Overall Survival

    5 years

Study Arms (2)

ketorolac 30 mg

EXPERIMENTAL

Active drug to be compared with placebo

Drug: Ketorolac 30 mg IV

NaCl 0.9% 3mL

PLACEBO COMPARATOR

Placebo looking like the Active drug

Drug: Placebos

Interventions

Ketorolac 30 mg IVDRUG

Active drug

Also known as: ketorolac tromethamine
ketorolac 30 mg
PlacebosDRUG

Placebo looking like the Active drug

Also known as: NaCl 0.9%
NaCl 0.9% 3mL

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio \>4 and/or "triple negative" histological status and/or Positive lymph nodes

You may not qualify if:

  • Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (3)

  • Forget P, Vandenhende J, Berliere M, Machiels JP, Nussbaum B, Legrand C, De Kock M. Do intraoperative analgesics influence breast cancer recurrence after mastectomy? A retrospective analysis. Anesth Analg. 2010 Jun 1;110(6):1630-5. doi: 10.1213/ANE.0b013e3181d2ad07. Epub 2010 Apr 30.

    PMID: 20435950BACKGROUND

  • Forget P, Bouche G, Duhoux FP, Coulie PG, Decloedt J, Dekleermaker A, Guillaume JE, Ledent M, Machiels JP, Mustin V, Swinnen W, van Maanen A, Vander Essen L, Verougstraete JC, De Kock M, Berliere M. Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial. PLoS One. 2019 Dec 4;14(12):e0225748. doi: 10.1371/journal.pone.0225748. eCollection 2019.

    PMID: 31800611DERIVED

  • Forget P, Berliere M, van Maanen A, Duhoux FP, Machiels JP, Coulie PG, Bouche G, De Kock M; Ketorolac in Breast Cancer trial (KBCtrial) group. Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial. Med Hypotheses. 2013 Oct;81(4):707-12. doi: 10.1016/j.mehy.2013.07.033. Epub 2013 Aug 9.

    PMID: 23937996DERIVED

Related Links

MeSH Terms

Interventions

KetorolacKetorolac TromethamineSodium Chloride

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Prof Patrice Forget
Organization
UoA
forgetpatrice@yahoo.fr
497 12 28 36

Study Officials

  • Patrice Forget, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docteur

Study Record Dates

First Submitted

February 20, 2013

First Posted

March 7, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2015

Study Completion

September 1, 2018

Last Updated

April 7, 2020

Results First Posted

January 18, 2020

Record last verified: 2020-03

Locations

BE(1)