Condition category
Cancer
Date applied
27/07/2011
Date assigned
18/10/2011
Last edited
16/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Julia Mayerle

ORCID ID

Contact details

Medical University of Greifswald
Department of Internal Medicine
Friedrich-Loeffler-Straße 23a
Greifswald
17475
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

23:07:2007

Study information

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

Acronym

NeoDox

Study hypothesis

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

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

Study design

Non-randomised open-label single-group interventional single-centre trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.medizin.uni-greifswald.de/gastro/Studien/magen-ca.htm [German]

Condition

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 names

Cisplatin, docetaxel, 5-FU

Primary outcome measures

Rate of curative (R0) resections after a neoadjuvant chemotherapy

Secondary outcome measures

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

Overall trial start date

01/09/2007

Overall trial end date

29/02/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

46

Participant 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

Recruitment start date

01/09/2007

Recruitment end date

29/02/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Medical University of Greifswald
Greifswald
17475
Germany

Sponsor information

Organisation

Medical University of Greifswald (Germany)

Sponsor details

Fleischmannstraße 8
Greifswald
17475
Germany

Sponsor type

University/education

Website

http://www.medizin.uni-greifswald.de/

Funders

Funder type

University/education

Funder name

Medical University of Greifswald (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/09/2016: Plain English summary added.