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A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer An IKZ-based phase II feasibility study

A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer An IKZ-based phase II feasibility study - DoCCS

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31603
Enrollment
50
Registered
2008-02-08
Start date
2008-03-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

gastric cancer gastric carcinoma

Interventions

Every patient included in this study will receive 4 courses of chemotherapy consisting of Taxotere, Xeloda and Cisplatin

Sponsors

Jeroen Bosch Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3 WHO or equal to 18 years No prior radio- or chemotherapy conflicting with the treatment of gastric cancer

Exclusion criteria

Exclusion criteria: Ia gastric cancer Other histological type than adenocarcinoma Distant metastases Inoperable patients Previous or other current malignancies Other current serious illness or medical conditions Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
- Assessment of the feasibility and toxicity efficacy/response rate (down-sizing/down-staging) of the combination of 4 courses of docetaxel/Taxotere*, cisplatin and capecitabine/Xeloda* as neoadjuvant chemotherapy in resectable localized or locally advanced gastric cancer - Percentage of patients who completed 4 courses of chemotherapy and proceeded to surgery - Surgical quality control in resectable gastric cancer - Establishment of toxicity and safety profile - Assessment of the reduction of tumour load with CT (or PET-CT) after neoadjuvant chemotherapy

Secondary

MeasureTime frame
- Introduction of a D1extra-resection as the standard surgical treatment - Percentage of complete pathological response - Percentage of complete pathological resection - Assessment of quality of life after treatment with neo-adjuvant chemotherapy and surgery in local or locally advanced gastric carcinoma

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)