An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer

NCT ID: NCT01442155

Last Updated: 2016-07-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Capecitabine + Oxaliplatin

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

Capecitabine

Intervention Type DRUG

Administered according to the Summary of Product Characteristics.

Oxaliplatin

Intervention Type BIOLOGICAL

Administered according to the Summary of Product Characteristics.

Interventions

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Capecitabine

Administered according to the Summary of Product Characteristics.

Intervention Type DRUG

Oxaliplatin

Administered according to the Summary of Product Characteristics.

Intervention Type BIOLOGICAL

Other Intervention Names

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Xeloda

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Contraindications according to the current Summary of Product Characteristics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Banská Bystrica, , Slovakia

Site Status

Bratislava, , Slovakia

Site Status

Bratislava, , Slovakia

Site Status

Košice, , Slovakia

Site Status

Martin, , Slovakia

Site Status

Nitra, , Slovakia

Site Status

Poprad, , Slovakia

Site Status

Prešov, , Slovakia

Site Status

Ružomberok, , Slovakia

Site Status

Countries

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Slovakia

Other Identifiers

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ML25526

Identifier Type: -

Identifier Source: org_study_id

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