Neoadjuvant chemotherapy in patients with locally advanced and /or nodal positive gastric cancer with Docetaxel, Cisplatin and 5-FU

Phase II trial for neoadjuvant chemotherapy in patients with locally advanced and /or nodal positive gastric cancer (UICC stages IIIa, IIIb and IV M0) with Docetaxel, Cisplatin and 5-FU

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43859589

Enrollment

Registered

2011-10-18

Start date

2007-09-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced and/or nodal positive gastric cancer (UICC Stages: IIIa, IIIb, IV M0) Cancer Malignant neoplasm of stomach

Interventions

1. Docetaxel: 75 mg/m2, (infusion, days 1, 22, 43) 2. Cisplatin: 75 mg/m2, (infusion, days 1, 22, 43) 3. 5-FU: 750 mg/(m2 x day), (infusion, days 1-5, 22-26, 43-47)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Locally advanced and/or node positive gastric adenocarcinoma (UICC stages IIIa, IIIb, IV and M0) 2. Aged 18 years and older 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0 - 2 4. Adequate organ function 5. Signed informed consent 6. Participants: patients of both genders, no healthy volunteers

Exclusion criteria

Exclusion criteria: 1. Metastatic disease 2. Prior chemotherapy for gastric cancer 3. Tumour recurrence after gastrectomy 4. Estimated life expectancy < 3 months 5. Presence of any serious concomitant systemic disorder

Design outcomes

Primary

Measure	Time frame
Rate of curative (R0) resections after a neoadjuvant chemotherapy	—

Secondary

Measure	Time frame
1. Median survival 2. Median progression-free survival 3. Remission rate 4. Toxicity of the protocol 5. Quality of life during neoadjuvant chemotherapy	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026