Clinical trial · Interventional
Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer
Phase 2 Clinical Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer: a Multicenter Randomized Placebo-controlled Double-blind Study to Investigate the Efficacy and Safety of ART-123
NCT02792842CI-TRIAL-00075703completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Stage II/III Colon Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ART-123 (1-day ART) | Drug | — | UNRESOLVED |
| ART-123 (3-day ART) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ART-123 (3-day ART)
- interventionNames
- Drug: ART-123 (3-day ART)
- type
- EXPERIMENTAL
- label
- ART-123 (1-day ART)
- interventionNames
- Drug: ART-123 (1-day ART)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (3)
- measure
- The Cumulative Rates of Participants With NCI-CTCAE Grade 2 or Higher Peripheral Sensory Neuropathy: Up to End of Study Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Main Inclusion Criteria: * Diagnosed with stage II / III colon cancer * Deemed to have undergone curative A (Cur A) surgery * Planning to undergo postoperative adjuvant chemotherapy Main Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDKotaka M, Saito Y, Kato T, Satake H, Makiyama A, Tsuji Y, Shinozaki K, Fujiwara T, Mizushima T, Harihara Y, Nagata N, Kurihara N, Ando M, Kusakawa G, Sakai T, Uchida Y, Takamoto M, Kimoto S, Hyodo I. A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy. Cancer Chemother Pharmacol. 2020 Nov;86(5):607-618. doi: 10.1007/s00280-020-04135-8. Epub 2020 Sep 23. PMID 32965539