NCT01442155

Brief Summary

This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

9 active sites

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

First Submitted

Initial submission to the registry

September 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 7, 2016

Completed
Last Updated

July 7, 2016

Status Verified

May 1, 2016

Enrollment Period

3.5 years

First QC Date

September 26, 2011

Results QC Date

May 26, 2016

Last Update Submit

May 26, 2016

Conditions

Colorectal Cancer

Keywords

Colorectal cancerAdjuvant settingCapecitabineOxaliplatin

Outcome Measures

Primary Outcomes (1)

  • Disease-Free Survival (Time to Event)

    Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).

    Up to 3 years

Secondary Outcomes (1)

  • Safety: Percentage of Participants With Adverse Events

    Up to 3 years

Study Arms (1)

Capecitabine + Oxaliplatin

Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.

Drug: CapecitabineBiological: Oxaliplatin

Interventions

CapecitabineDRUG

Administered according to the Summary of Product Characteristics.

Also known as: Xeloda
Capecitabine + Oxaliplatin
OxaliplatinBIOLOGICAL

Administered according to the Summary of Product Characteristics.

Capecitabine + Oxaliplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with Stage III colon cancer

You may qualify if:

  • Adult participants, \>/= 18 years of age
  • Treatment in line with the currently approved indication in the Summary of Product Characteristics

You may not qualify if:

  • Contraindications according to the current Summary of Product Characteristics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Banská Bystrica, 975 17, Slovakia

Location

Unknown Facility

Bratislava, 812 50, Slovakia

Location

Unknown Facility

Bratislava, 833 10, Slovakia

Location

Unknown Facility

Košice, 04001, Slovakia

Location

Unknown Facility

Martin, 036 59, Slovakia

Location

Unknown Facility

Nitra, 950 01, Slovakia

Location

Unknown Facility

Poprad, 058 01, Slovakia

Location

Unknown Facility

Prešov, 081 81, Slovakia

Location

Unknown Facility

Ružomberok, 03426, Slovakia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

CapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800 821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2011

First Posted

September 28, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 7, 2016

Results First Posted

July 7, 2016

Record last verified: 2016-05

Locations

SL(9)