Clinical trial · Interventional
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
- 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)
Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma. But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice. Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities. But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens. GemOx has been reported to be effective and have very favorable toxicity profiles.
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 |
|---|---|---|---|
| Advanced Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GCb | Drug | — | UNRESOLVED |
| GemOx | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- GCb
- description
- Gemcitabine plus Carboplatin
- interventionNames
- Drug: GCb
- type
- EXPERIMENTAL
- label
- GemOx
- description
- Gemcitabine plus Oxaliplatin
- interventionNames
- Drug: GemOx
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 12 weeks
- description
- Response rate based on RECIST 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically of histologically confirmed urothelial carcinoma * Locally advanced or metastatic disease * Measurable disease according to RECIST v.1.1 * ECOG PS 0-2 * Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2) * Adequate organ function * Chemotherapy-naive Exclusion Criteria: * Histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed * CNS metastases * Peripheral neuropathy grade 2 or worse * Serious medical or surgical conditions
References
Publications (1)
- DERIVEDPark I, Kim BS, Lim HY, Kim HJ, Lee HJ, Choi YJ, Park KH, Lee KH, Yoon S, Hong B, Hong JH, Ahn H, Lee JL. Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16). Eur J Cancer. 2020 Mar;127:183-190. doi: 10.1016/j.ejca.2019.08.034. Epub 2019 Oct 24. PMID 31668839