Trial Outcomes & Findings for An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer (NCT NCT01664494)
NCT ID: NCT01664494
Last Updated: 2016-05-02
Results Overview
Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.
Recruitment status
COMPLETED
Target enrollment
563 participants
Primary outcome timeframe
Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
Results posted on
2016-05-02
Participant Flow
A total of 563 participants were included from April 2010 to July 2012 at 21 sites in Austria.
Of 563 participants, 220 were treated for adjuvant colon cancer, 200 were treated for metastatic colorectal cancer, 84 were treated for metastatic breast cancer, and 59 were treated for advanced gastric cancer.
Participant milestones
| Measure |
Capecitabine
Participants received capecitabine according to the label text as monotherapy (1250 mg/m\^2 twice daily) or combination therapy (800 to 1000 mg/m\^2 or 1250 mg/m\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
|
|---|---|
|
Overall Study
STARTED
|
563
|
|
Overall Study
COMPLETED
|
370
|
|
Overall Study
NOT COMPLETED
|
193
|
Reasons for withdrawal
| Measure |
Capecitabine
Participants received capecitabine according to the label text as monotherapy (1250 mg/m\^2 twice daily) or combination therapy (800 to 1000 mg/m\^2 or 1250 mg/m\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
27
|
|
Overall Study
Death
|
18
|
|
Overall Study
Other
|
49
|
|
Overall Study
Lost to Follow-up
|
99
|
Baseline Characteristics
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer
Baseline characteristics by cohort
| Measure |
Capecitabine
n=563 Participants
Participants received capecitabine according to the label text as monotherapy (1250 mg/m\^2 twice daily) or combination therapy (800 to 1000 mg/m\^2 or 1250 mg/m\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
|
|---|---|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred firstPopulation: All enrolled participants were considered for this outcome measure.
Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.
Outcome measures
| Measure |
Capecitabine
n=563 Participants
Participants received capecitabine according to the label text as monotherapy (1250 mg/m\^2 twice daily) or combination therapy (800 to 1000 mg/m\^2 or 1250 mg/m\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
|
|---|---|
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Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment
Adjuvant therapy
|
220 Participants
|
|
Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment
First line therapy
|
176 Participants
|
|
Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment
Second line therapy
|
89 Participants
|
|
Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment
Third line therapy
|
78 Participants
|
SECONDARY outcome
Timeframe: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred firstPopulation: All enrolled participants were considered for this outcome measure.
Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.
Outcome measures
| Measure |
Capecitabine
n=563 Participants
Participants received capecitabine according to the label text as monotherapy (1250 mg/m\^2 twice daily) or combination therapy (800 to 1000 mg/m\^2 or 1250 mg/m\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
|
|---|---|
|
Median Dose of Capecitabine
Month 7
|
3500 Milligrams
Interval 1500.0 to 5000.0
|
|
Median Dose of Capecitabine
From Month 8 onwards
|
3000 Milligrams
Interval 900.0 to 5000.0
|
Adverse Events
Capecitabine
Serious events: 34 serious events
Other events: 271 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine
n=563 participants at risk
Participants received capecitabine according to the label text as monotherapy (1250 mg/m\^2 twice daily) or combination therapy (800 to 1000 mg/m\^2 or 1250 mg/m\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
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|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Cardiac disorders
Cardiac arrest
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Cardiac disorders
Cardiac failure
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
3/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
7/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Enteritis
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
0.89%
5/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
6/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Stomatitis
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
General disorders
Death
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
General disorders
Disease progression
|
1.2%
7/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
General disorders
General physical health deterioration
|
1.2%
7/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
General disorders
Multiple Organ Failure
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Infections and infestations
Sepsis
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Investigations
Inflammatory marker increased
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.36%
2/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Nervous system disorders
Hypertonia
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.53%
3/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.89%
5/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Vascular disorders
Hypertension
|
0.18%
1/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
Other adverse events
| Measure |
Capecitabine
n=563 participants at risk
Participants received capecitabine according to the label text as monotherapy (1250 mg/m\^2 twice daily) or combination therapy (800 to 1000 mg/m\^2 or 1250 mg/m\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
30.6%
172/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
117/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
19.5%
110/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Stomatitis
|
11.2%
63/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
31/563 • Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER