Neoadjuvant chemotherapy in patients with locally advanced and /or nodal positive gastric cancer with Docetaxel, Cisplatin and 5-FU
| ISRCTN | ISRCTN43859589 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43859589 |
| Protocol serial number | 23:07:2007 |
| Sponsor | Medical University of Greifswald (Germany) |
| Funder | Medical University of Greifswald (Germany) |
- Submission date
- 27/07/2011
- Registration date
- 18/10/2011
- Last edited
- 16/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Gastric cancer is a fairly uncommon type of cancer that develops from the lining of the stomach. Cancer that begins in the stomach and spreads to another part of the body or comes back after treatment is termed advanced stomach cancer. Despite the use of aggressive chemotherapies (medicines that stop cancer cells from dividing and multiplying), the outlook for patients with advanced gastric cancer is rather poor. Even after radical surgery, the overall 5-year survival rate is 20 – 30 % in Europe. Chemotherapy can be given before surgery to try to shrink the tumour so it may then be easier to remove. This type of treatment is called neoadjuvant chemotherapy. The aim of this study is to assess the effectiveness and toxicity (side effects) of neoadjuvant chemotherapy with the drugs docetaxel, cisplatin and 5-FU.
Who can participate?
Patients aged 18 and older with advanced gastric cancer
What does the study involve?
Chemotherapy treatment is given in three cycles, which start on days 1, 22 and 43. For safety monitoring, blood samples are taken on a weekly basis, heart activity is monitored and side effects are recorded. Participants are assessed to see whether the cancer can be fully removed in surgery (curative resection). Side effects and quality of life are also assessed to measure the impact of the disease and chemotherapy on daily life.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Medical University of Greifswald (Germany)
When is the study starting and how long is it expected to run for?
September 2007 to February 2012
Who is funding the study?
Medical University of Greifswald (Germany)
Who is the main contact?
Prof. Julia Mayerle
Contact information
Scientific
Medical University of Greifswald
Department of Internal Medicine
Friedrich-Loeffler-Straße 23a
Greifswald
17475
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised open-label single-group interventional single-centre trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study acronym | NeoDox |
| Study objectives | A neoadjuvant chemotherapy in patients with advanced gastric cancer is expected to improve R0 surgical resection and therefore prolong survival of these patients |
| Ethics approval(s) | Ethics Committee at the Medical Faculty of the University of Greifswald [Ethikkommission an der Medizinischen Fakultät der Universität Greifswald], 26/02/2004, ref: III UV 10/04 |
| Health condition(s) or problem(s) studied | Locally advanced and/or nodal positive gastric cancer (UICC Stages: IIIa, IIIb, IV M0) |
| Intervention | 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) |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Cisplatin, docetaxel, 5-FU |
| Primary outcome measure(s) |
Rate of curative (R0) resections after a neoadjuvant chemotherapy |
| Key secondary outcome measure(s) |
1. Median survival |
| Completion date | 29/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 46 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 29/02/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
17475
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/09/2016: Plain English summary added.
