Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer
- Conditions
- Postoperative Stage II/III Colon Cancer
- Interventions
- Drug: ART-123 (3-day ART)Drug: ART-123 (1-day ART)Drug: Placebo
- Registration Number
- NCT02792842
- Lead Sponsor
- Asahi Kasei Pharma Corporation
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- Diagnosed with stage II / III colon cancer
- Deemed to have undergone curative A (Cur A) surgery
- Planning to undergo postoperative adjuvant chemotherapy
Main
- Have a history of hypersensitivity to any of the ingredients in thrombomodulin alfa (recombinant)
- Have any treatment history of systemic chemotherapy (including any drug in the clinical trial stage) or radiotherapy
- With active double cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ART-123 (3-day ART) ART-123 (3-day ART) - ART-123 (1-day ART) ART-123 (1-day ART) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method The Cumulative Rates of Participants With NCI-CTCAE Grade 2 or Higher Peripheral Sensory Neuropathy: Up to End of Study Treatment 42 days after the start of cycle 12 (each cycle is 2 weeks). NCI-CTCAE was used for investigator-reported outcomes of peripheral sensory neuropathy; it was assessed every day from day 1 to day 3 of each cycle and on days 15 (the day after 14 days have elapsed from the date of administration) of Cycle 12 and 43 (the day after 42 days have elapsed from the date of administration of Cycle 12) of cycle 12 as follow-up assessment. Once grade 2 or higher neuropathy was observed in a certain participant, that participant was categorized as grade 2 or higher even if the grade returned to 1 or lower in subsequent cycles. Participants who discontinued the study or whose evaluation data were missing without reaching grade 2 or higher neuropathy were analyzed as no grade 2 or higher neuropathy. No primary endpoint was specified due to the exploratory nature of the study.
Least-squares (LS) Means of Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) Version 4.0 Score at Cycle 12 At baseline, at each cycle (up to cycle 12 with each cycle of 2 weeks), and follow-up assessment. Participant-reported outcomes were evaluated using the FACT/GOG-Ntx-12 version 4.0, which measured the severity and impact of symptoms of neuropathy over the past 7 days. Scores range from 0 to 48, with lower scores indicating more severe neurotoxicity. Participants completed paper questionnaires on days 1 and 8 of each cycle, on day 15 (the day after 14 days have elapsed from the date of administration) of cycle 12 and day 43 (the day after 42 days have elapsed from the date of administration) of cycle 12 as follow-up assessment. LS means were calculated from the mixed effect model for repeated measures (MMRM). Analysis included the fixed, categorical effects of study treatment, analysis visit, and study treatment-by-visit interaction. If multiple measurements occurred within the same visit, the measurement with the worst value was used. No primary endpoint was specified due to the exploratory nature of the study.
The Discontinuation Rate of Oxaliplatin Due to Oxaliplatin-Induced Peripheral Neuropathy (OIPN) Cycle 12（each cycle is 2 weeks） The number of people who discontinued oxaliplatin because of OIPN was counted and the percentage of the total was calculated. No primary endpoint was specified due to the exploratory nature of the study.
- Secondary Outcome Measures
Name Time Method