eoadjuvant chemotherapy in patients with locally advanced and /or nodal positive gastric cancer with Docetaxel, Cisplatin and 5-F
Phase 2
Completed
- Conditions
- ocally advanced and/or nodal positive gastric cancer (UICC Stages: IIIa, IIIb, IV M0)CancerMalignant neoplasm of stomach
- Registration Number
- ISRCTN43859589
- Lead Sponsor
- Medical University of Greifswald (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 46
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of curative (R0) resections after a neoadjuvant chemotherapy
- Secondary Outcome Measures
Name Time Method 1. Median survival<br>2. Median progression-free survival<br>3. Remission rate<br>4. Toxicity of the protocol<br>5. Quality of life during neoadjuvant chemotherapy