Gastric CancerPhase 2DoCCSNCT01517009
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
A Phase 2 study testing Docetaxel, cisplatin and Capecitabine in people with Gastric Cancer, run by Jeroen Bosch Ziekenhuis at 5 sites in Netherlands.
Trial summary
The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Docetaxel, cisplatin and Capecitabine
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 5 sitesNetherlands
- Study dates
- Jun 2008to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3
- ASA 2 or less
- Age 18 years or more
- No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
- Haematology/Renal function/Liver function within designated range
- Patient's consent form obtained, signed and dated before beginning specific protocol procedures
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- before patient registration/randomization, written informed consent must be given according to GCP, WMO and local regulations.
Who cannot join
- Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer
- Other current serious illness or medical conditions
- Severe cardiac illness (NYHA class III-IV)
- Significant neurologic or psychiatric disorders
- Uncontrolled infections
- Active DIC
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- Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
- Known hypersensitivity to docetaxel (or any drug formulated with Polysorbate-80), or cisplatin or capecitabine or 5-FU
- Definite contraindications for the use of corticosteroids
- Use of immunosuppressive or antiviral drugs
- Any other experimental drugs within a 4-week period prior to start of neoadjuvant chemotherapy and throughout the study period
- Pregnant or lactating women
- Patients with reproductive potential not implementing adequate contraceptive measures
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, 5200 ME
Catharina Hospital
Eindhoven, North Brabant, 5602 ZA
Elkerliek Hospital
Helmond, North Brabant, 5700 AB
Maxima Medical Centre
Veldhoven, North Brabant, 5500 MB
VieCuri Hospital
Venlo, Limburg, 5912 BL
About this study
The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented.
- Conditions
- Gastric Cancer
- Being tested
- Docetaxel, cisplatin, Capecitabine, D1extra-resection
- Keywords
- Neo-adjuvant chemotherapy, D1extra-resection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
60 mg/m2, 1 gift every 3 weeks, in total 4 gifts
cisplatinDrug
60 mg/m2, one gift every three weeks, in total 4 gift
CapecitabineDrug
Also called Xeloda
1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles
D1extra-resectionProcedure or surgery
An extended lymphadenectomy compared to a D1 resection for gastric cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer.
Patients receive every 3 weeks a cycle of chemotherapy, in total 4 cylcles will be given. Surgery will be performed approximately 6 weeks after the last cycle.
Measured: 18 weeks
Secondary outcomes (1)
The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJun 2008
- Primary completionNov 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeroen Bosch Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven Cancer Registry
- Responsible party
- Principal investigator, Anneriet Dassen, Jeroen Bosch Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517009
- Sponsor's protocol ID
- DoCCS
- Other IDs
- Dutch trialregister, 2007-007273-23
- Acronym
- DoCCS
- Status last verified
- Jun 2013
- First submitted
- 21 Oct 2011
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT01517009
- Acronym / sponsor ID
- DoCCS / DoCCS
- Conditions
- Gastric Cancer
- Keywords
- Neo-adjuvant chemotherapy, D1extra-resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jeroen Bosch ZiekenhuisUniversity, hospital or other
- Collaborators
- Eindhoven Cancer Registry
- Study start
- Jun 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3
- ASA 2 or less
- Age 18 years or more
- No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
- Haematology/Renal function/Liver function within designated range
Key exclusion criteria (13 listed)
- Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer
- Other current serious illness or medical conditions
- Severe cardiac illness (NYHA class III-IV)
- Significant neurologic or psychiatric disorders
- Uncontrolled infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Taxotere60 mg/m2, 1 gift every 3 weeks, in total 4 gifts | Drug | – |
| cisplatin60 mg/m2, one gift every three weeks, in total 4 gift | Drug | – |
| CapecitabineAlso: Xeloda1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles | Drug | – |
| D1extra-resectionAn extended lymphadenectomy compared to a D1 resection for gastric cancer | Procedure or surgery | – |
Primary outcome
The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer.
Time frame: 18 weeks
Patients receive every 3 weeks a cycle of chemotherapy, in total 4 cylcles will be given. Surgery will be performed approximately 6 weeks after the last cycle.
1 secondary outcome
The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, cisplatin and Capecitabine in people with Gastric Cancer, run by Jeroen Bosch Ziekenhuis at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer. (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.