Trial Outcomes & Findings for An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer (NCT NCT01442155)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

74 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2016-07-07

Participant Flow

Two participants were screening failures. 74 participants were assigned to the study and treated with study drug.

Participant milestones

Participant milestones
Measure	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: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics.
Overall Study STARTED	74
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	65

Reasons for withdrawal

Reasons for withdrawal
Measure	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: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics.
Overall Study Complete remission	35
Overall Study Recurrence	26
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine + Oxaliplatin n=74 Participants Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. Capecitabine: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics.
Age, Continuous	58.6 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Intent-to-treat (ITT) population included all participants treated with at least one dose of study drug. Here, number of participants analyzed is number evaluable for efficacy.

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).

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=67 Participants Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. Capecitabine: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics.
Disease-Free Survival (Time to Event)	25 months Interval 15.1 to 34.9

SECONDARY outcome

Timeframe: Up to 3 years

Population: Safety population included all participants treated with at least one dose of study drug.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=74 Participants Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. Capecitabine: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics.
Safety: Percentage of Participants With Adverse Events	39.19 percentage of participants

Adverse Events

Capecitabine + Oxaliplatin

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Capecitabine + Oxaliplatin n=74 participants at risk Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. Capecitabine: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/74 • Up to 3 years

Other adverse events

Other adverse events
Measure	Capecitabine + Oxaliplatin n=74 participants at risk Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. Capecitabine: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics.
Blood and lymphatic system disorders Thrombocytopenia	10.8% 8/74 • Up to 3 years
Gastrointestinal disorders Diarrhea	10.8% 8/74 • Up to 3 years
Gastrointestinal disorders Nausea	6.8% 5/74 • Up to 3 years
Nervous system disorders Neuropathy peripheral	9.5% 7/74 • Up to 3 years
Nervous system disorders Paresthesia	5.4% 4/74 • Up to 3 years

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

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