Clinical trial · Interventional
Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma
A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
- 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)
Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCF (docetaxel with cisplatin with 5-FU) | Drug | — | UNRESOLVED |
| DCS (docetaxel with cisplatin with TS-1) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- DCS
- description
- DCS: docetaxel with cisplatin with TS-1
- interventionNames
- Drug: DCS (docetaxel with cisplatin with TS-1)
- type
- ACTIVE_COMPARATOR
- label
- DCF
- description
- DCF : docetaxel with cisplatin with 5-FU
- interventionNames
- Drug: DCF (docetaxel with cisplatin with 5-FU)
Primary outcomes (1)
- measure
- RECIST(Response Evaluation Criteria in Solid Tumors)
- timeFrame
- written in the description part below
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically/cytologically confirmed gastric adenocarcinoma * Age 18 to 70 years old * ECOG performance Status 0\~1 * Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA\~IV), M0, P0, H0, CY0 * No pretreatment (radiotherapy or chemotherapy) for gastric cancer * Adequate organ function * Hb ≥ 9.0 g/dL * WBC ≥ 4,000/µL * ANC ≥ 2,000/µL (\*ANC = Neutrophil segs ＋ Neutrophil bands) * Platelet ≥ 100 × 103/ µL * Total bilirubin: ≤ 1.5 × UNL * CCr ≥ 60 ml/min (by laboratory or Cockcroft-Gault Formula) * AST/ALT, ALP: ≤ 2.5 × UNL * Written informed consent Exclusion Criteria: * Distant metastasis on diagnosis * cT1-2 * Cancer of gastroesophageal junction (GEJ) * Poor oral intake or absorption deficiency syndrome * Gastric outlet obstruction, perforation or bleeding * Medically uncontrollable chronic illness or infection * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * History of clinically significant cardiac disease * Past or concurrent history of neoplasm last \< 5 year other than gastric cancer * Prior gastrectomized patients * Concomitant administration of any other experimental drug under investigation * Peripheral neuropathy ≥ NCI-CTC grade 2
References
Publications (0)
Data not yet available