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

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Capecitabine; Drug: Chemotherapy

• Registration Number: NCT01696695
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-09-22
• Results First Submitted QC: 2016-09-22
• Results First Posted: 2016-11-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 882

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic Colorectal Carcinoma (mCRC) Participants	Chemotherapy	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.
Metastatic Colorectal Carcinoma (mCRC) Participants	Capecitabine	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.

Primary Outcome Measures

Name	Time	Method
Median Progression-free Survival (PFS)	Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254	PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day. PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.
PFS by Therapeutic Regimens	Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254	PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1	Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254	Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (\<) 10 mm). No new lesions.PR was defined as greater than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Percentage of Participants With Dose Modification of Capecitabine	Baseline up to 1254 days
Percentage of Participants Who Underwent Metastasectomy	Baseline up to 1254 days	Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.
Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1	Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254	Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis \<10 mm).No new lesions.PR: \>=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions.
Mean Duration of Capecitabine Therapy	Baseline up to 1254 days

Trial Locations

Locations (22)

Josa Andras Korhaz; Dept of Oncoradiology; 🇭🇺 Nyíregyháza, Hungary

Zala megyei Önkormányzat Kórház és Rendelõintézet; 🇭🇺 Zalaegerszeg, Hungary

Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika; 🇭🇺 Budapest, Hungary

Veszprem Megyei Csolnoky; Ferenc Korhaz; 🇭🇺 Veszprem, Hungary

Fövárosi Önkormányzat uzsoki utcai Kórház; 🇭🇺 Budapest, Hungary

Kenezy Korhaz Rendelointezet; 🇭🇺 Debrecen, Hungary

Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek; 🇭🇺 Gyula, Hungary

Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont; 🇭🇺 Kecskemet, Hungary

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika; 🇭🇺 Szeged, Hungary

Szent Gyorgy Korhaz;Fejer Megyei; 🇭🇺 Szekesfehervar, Hungary

Tolna Megyei Onkormanyzat Balassa Janos Korhaz; 🇭🇺 Szekszard, Hungary

Vas Megyei Markusovszky Korhaz X; Oncoradiology; 🇭🇺 Szombathely, Hungary

Dr. Bugyi Istvan Korhaz; 🇭🇺 Szentes, Hungary

Petz Aladar Megyei Oktato Korhaz; 🇭🇺 Gyor, Hungary

Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly; 🇭🇺 Miskolc, Hungary

Pest Megyei Flor Korhaz; Oncology; 🇭🇺 Kistarcsa, Hungary

Pécsi Tudományegyetem Áok; Onkoterapias Intezet; 🇭🇺 Pecs, Hungary

Szent Borbala Korhaz; 🇭🇺 Tatabanuya, Hungary

Szent Lázár Kórház; 🇭🇺 Salgótarján, Hungary

Szent Margit Hospital; 🇭🇺 Budapest, Hungary

Semmelweis Egyetem, II. Belgyógyászati Klinika; 🇭🇺 Budapest, Hungary

Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.; 🇭🇺 Budapest, Hungary