Gastric CancerPhase 3NCT00005060
Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer
A Phase 3 study testing Taxotere-Cisplatin-5FU and Immediate surgery in people with Gastric Cancer, run by Swiss Cancer Institute at 3 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Taxotere-Cisplatin-5FU and Immediate surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 1999to Mar 2006
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed locally advanced gastric carcinoma that is considered operable
- T3-4, Nx, M0 OR
- Tx, N+, M0
- Lymph nodes considered positive by sonography should be at least 2 of the following:
- Round
- Echopoor
- Sharp borders
- At least 0.5 cm
- No distant metastases, including peritoneal carcinomatosis
- CT scan and peritoneal lavage mandatory
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- 0-2
Life expectancy:
- Greater than 12 weeks
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- AST or ALT no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Adequate renal function within limits to allow for treatment with cisplatin
Cardiovascular:
- No unstable cardiac disease requiring treatment
- No congestive heart failure or angina pectoris even if medically controlled
- No significant arrhythmias
- No myocardial infarction within past 6 months
- Ejection fraction greater than 50% on cardiac sonography or MUGA scan
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix
- No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic)
- No history of anaphylaxis
- No other serious concurrent illness or medical condition that would preclude study therapy
- No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy for gastric carcinoma
Chemotherapy:
- No other concurrent chemotherapy for gastric carcinoma
Endocrine therapy:
- No concurrent endocrine therapy for gastric carcinoma
Radiotherapy:
- No concurrent radiotherapy for gastric carcinoma
Surgery:
- See Disease Characteristics
Other:
- At least 30 days since prior treatment in a clinical trial
- No other concurrent experimental drugs
- No other concurrent anticancer therapy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
Hopital Cantonal Universitaire de Geneve
Geneva, CH-1211
Zentrum fuer Tumordiagnostikund Praevention
Sankt Gallen, CH-9006
About this study
Official title: A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.
PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.
Read the detailed description
OBJECTIVES:
- Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma.
- Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II).
- Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection.
- Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.
Quality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months.
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.
- Conditions
- Gastric Cancer
- Being tested
- Taxotere-Cisplatin-5FU, Immediate surgery
- Keywords
- stage II gastric cancer, stage III gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxotere-Cisplatin-5FUDrug
Preoperatively
Immediate surgeryDrug
Immediate surgery followed by Taxotere-Cisplatin-5FU
| Study group | Role | What they receive |
|---|---|---|
| Taxotere-Cisplatin-5FU preoperatively | Active comparator | TCF preoperatively Receives: Drug: Taxotere-Cisplatin-5FU |
| Immediate surgery followed by TCF | Active comparator | Surgery followed by Taxotere-Cisplatin-5FU Receives: Drug: Immediate surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Secondary outcomes (4)
Overall survival
Time to treatment failure measured after completion of study treatment
Toxicity measured after completion of study treatment
Rate of complete resection (RO) and postoperative mortality as measured after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 1999
- Primary completionNov 2005
- Study completionMar 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf Morant, MD, Study chair, Tumor Zentrum ZeTup St. Gallen und Chur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005060
- Sponsor's protocol ID
- SAKK 43/99
- Other IDs
- SWS-SAKK-43/99, EU-99042
- Status last verified
- May 2012
- First submitted
- 6 Apr 2000
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma
- ClinicalTrials.gov ID
- NCT00005060
- Acronym / sponsor ID
- SAKK 43/99
- Conditions
- Gastric Cancer
- Keywords
- stage II gastric cancer, stage III gastric cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Nov 1999
- Primary completion
- Nov 2005 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.
PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.
Detailed description
OBJECTIVES:
- Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma.
- Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II).
- Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection.
- Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.
Quality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months.
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxotere-Cisplatin-5FU preoperatively | Active comparator | Drug: Taxotere-Cisplatin-5FUTCF preoperatively |
| Immediate surgery followed by TCF | Active comparator | Drug: Immediate surgerySurgery followed by Taxotere-Cisplatin-5FU |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Taxotere-Cisplatin-5FUPreoperatively | Drug | Taxotere-Cisplatin-5FU preoperatively |
| Immediate surgeryImmediate surgery followed by Taxotere-Cisplatin-5FU | Drug | Immediate surgery followed by TCF |
Primary outcome
Event-free survival
4 secondary outcomes
Overall survival
Time to treatment failure measured after completion of study treatment
Toxicity measured after completion of study treatment
Rate of complete resection (RO) and postoperative mortality as measured after surgery
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 15 May 2012.
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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.
Rudolf Morant, MD study chair
Tumor Zentrum ZeTup St. Gallen und Chur
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Taxotere-Cisplatin-5FU and Immediate surgery in people with Gastric Cancer, run by Swiss Cancer Institute at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Event-free survival. 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 15 May 2012.