An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer

NCT ID: NCT01696695

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 882 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-12-31

Brief Summary

This observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Metastatic Colorectal Carcinoma (mCRC) Participants

Newly diagnosed mCRC participants, who will receive first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, will be observed. The choice of therapy is based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also do not specify any treatment regimen.

Capecitabine

Intervention Type: DRUG

First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics

Chemotherapy

Intervention Type: DRUG

First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy.

Interventions

Capecitabine

First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics

Intervention Type: DRUG

Chemotherapy

First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy.

Intervention Type: DRUG

Other Intervention Names

Xeloda

Eligibility Criteria

Inclusion Criteria

• Participants with newly diagnosed mCRC who have started first-line capecitabine-based chemotherapy in accordance with the current Hungarian label

Exclusion Criteria

• History of serious or unexpected reaction to fluoropyrimidine therapy
• Hypersensitivity to the active ingredient of Xeloda or to any of the excipients of the product, or to fluorouracil
• Known dihydropyrimidine dehydrogenase deficiency
• Pregnancy or lactation
• Inadequate bone marrow, hepatic or renal function
• Treatment with sorivudine or its chemical analogues (for example, brivudine)
• If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Szent Margit Hospital

Budapest, , Hungary

Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.

Budapest, , Hungary

Semmelweis Egyetem, II. Belgyógyászati Klinika

Budapest, , Hungary

Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

Budapest, , Hungary

Fövárosi Önkormányzat uzsoki utcai Kórház

Budapest, , Hungary

Kenezy Korhaz Rendelointezet

Debrecen, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

Gyula, , Hungary

Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

Kecskemét, , Hungary

Pest Megyei Flor Korhaz; Oncology

Kistarcsa, , Hungary

Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

Miskolc, , Hungary

Josa Andras Korhaz; Dept of Oncoradiology

Nyíregyháza, , Hungary

Pécsi Tudományegyetem Áok; Onkoterapias Intezet

Pécs, , Hungary

Szent Lázár Kórház

Salgótarján, , Hungary

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

Szeged, , Hungary

Tolna Megyei Onkormanyzat Balassa Janos Korhaz

Szekszárd, , Hungary

Dr. Bugyi Istvan Korhaz

Szentes, , Hungary

Szent Gyorgy Korhaz;Fejer Megyei

Székesfehérvár, , Hungary

Vas Megyei Markusovszky Korhaz X; Oncoradiology

Szombathely, , Hungary

Szent Borbala Korhaz

Tatabanuya, , Hungary

Veszprem Megyei Csolnoky; Ferenc Korhaz

Veszprém, , Hungary

Zala megyei Önkormányzat Kórház és Rendelõintézet

Zalaegerszeg, , Hungary

Countries

Hungary

Other Identifiers

ML27791

Identifier Type: -

Identifier Source: org_study_id