NCT03177317

Brief Summary

Feasibility study to evaluate the efficacy of reduced prophylactic dose of dexamethasone in elderly patients receiving moderate emetogenic chemotherapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

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

May 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

2.7 years

First QC Date

June 4, 2017

Last Update Submit

December 1, 2020

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Complete response (CR)

    No emetic episode, no rescue medicine

    2 weeks

Secondary Outcomes (2)

  • Complete control (CC)

    2 weeks

  • Complete protection (CP)

    2 weeks

Study Arms (1)

Elderly patients (>= 70 years of age)

EXPERIMENTAL

Dexamethasone 8mg intravenously before chemotherapy

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Dexamethasone 8mg IV before chemotherapy on cycle 1 day 1 Once the complete response is achieved, the dose of dexamethasone will be reduced by 2 mg in the next cycle.

Elderly patients (>= 70 years of age)

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histopathologically confirmed colorectal cancer patients with curative resection
  • ECOG performance status 0-2
  • Provision of signed, written and dated informed consent prior to any study specific procedures
  • Receiving adjuvant chemotherapy with FOLFOX (5-FU, leucovorin, oxaliplatin) regimen

You may not qualify if:

  • Having contraindication to dexamethasone
  • Having nausea or vomiting before the start of adjuvant chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Jin Won Kim, M.D., PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2017

First Posted

June 6, 2017

Study Start

May 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

December 2, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)