Back to resultsA Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer (DoCCS)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Docetaxel
cisplatin
Capecitabine
D1extra-resection
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Neo-adjuvant chemotherapy, D1extra-resection
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- VieCuri Hospital
- Elkerliek Hospital
- Jeroen Bosch Hospital
- Catharina Hospital
- Maxima Medical Centre
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer
Full Information
NCT ID
NCT01517009
First Posted
October 21, 2011
Last Updated
June 25, 2013
Sponsor
Jeroen Bosch Ziekenhuis
Collaborators
Eindhoven Cancer Registry
1. Study Identification
Unique Protocol Identification Number
NCT01517009
Brief Title
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
Acronym
DoCCS
Official Title
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jeroen Bosch Ziekenhuis
Collaborators
Eindhoven Cancer Registry
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Neo-adjuvant chemotherapy, D1extra-resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
60 mg/m2, 1 gift every 3 weeks, in total 4 gifts
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
60 mg/m2, one gift every three weeks, in total 4 gift
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles
Intervention Type
Procedure
Intervention Name(s)
D1extra-resection
Intervention Description
An extended lymphadenectomy compared to a D1 resection for gastric cancer
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Facility Information:
Facility Name
VieCuri Hospital
City
Venlo
State/Province
Limburg
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Elkerliek Hospital
City
Helmond
State/Province
Noord Brabant
ZIP/Postal Code
5700 AB
Country
Netherlands
Facility Name
Jeroen Bosch Hospital
City
Den Bosch
State/Province
Noord-Brabant
ZIP/Postal Code
5200 ME
Country
Netherlands
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5602 ZA
Country
Netherlands
Facility Name
Maxima Medical Centre
City
Veldhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5500 MB
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
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