Resected Advanced Gastric CancerPhase 2NCT00976976
Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer: Adjuvant DXP
A Phase 2 study testing docetaxel, capecitabine, cisplatin in people with Resected Advanced Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Despite the improvement of surgical resection as primary curative treatment for gastric cancer, more than 70% of patients with stage IIIB and IV disease undergoing radical primary tumor resection relapse and die within 5 years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Resected Advanced Gastric Cancer
- What is being tested?
- docetaxel, capecitabine, cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2007to Sep 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented gastric adenocarcinoma
- Age 18 -70
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Pathologic stage IIIB or IV
- complete resection (R0 resection)
Who cannot join
- Other tumor type than adenocarcinoma
- R1 or R2 resection
- Presence of distant metastasis
- Gastric outlet obstruction or intestinal obstruction
- Evidence of gastrointestinal bleeding
- Other serious illness or medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer
Despite the improvement of surgical resection as primary curative treatment for gastric cancer, more than 70% of patients with stage IIIB and IV disease undergoing radical primary tumor resection relapse and die within 5 years. Therefore, there is an urgent need to further improve the treatment for gastric cancer in this population. Recently reported phase III study comparing capecitabine/cisplatin (XP) versus 5-FU/cisplatin (FP), XP showed better activity and tolerability compared with FP. To improve treatment outcomes of XP chemotherapy, the investigators performed a phase I-II study of docetaxel, capecitabine and cisplatin in advanced gastric cancer (AGC). Phase I-II study of docetaxel, capecitabine and cisplatin as first-line chemotherapy in advanced gastric cancer (Kang et al, Proc Am Soc Clin Oncol 22,328.2003). The docetaxel/capecitabine/cisplatin (DXP) chemotherapy was highly active for the 1st-line chemotherapy of AGC. These findings and experience encourages the investigators to design the adjuvant trial of DXP chemotherapy in patients with resected gastric cancer. The aim of this study is to assess the efficacy and safety of adjuvant DXP in this patient population.
Read the detailed description
Previous in phase II study of docetaxel, capecitabine and cisplatin,total 40 pts with measurable disease, median 6 cycles of chemotherapy, there were 4 confirmed complete responses (CRs) and 23 confirmed partial responses (PRs), with the overall response rate of 67.5% (95% confidence interval, 52.7 ~ 82.3) in intention-to-treat analysis. Ten patients underwent surgical resection after 4 ~ 9 cycles of chemotherapy. Four pathologic CRs were identified. With a median follow-up of 14 months (range, 1 to 28), median time to progression was 7.7 months, and median overall survival was 16.9 months. The DXP chemotherapy was highly active for the 1st-line chemotherapy of AGC (Kang et al, Proc Am Soc Clin Oncol 22,328.2003).
- Conditions
- Resected Advanced Gastric Cancer
- Being tested
- docetaxel, capecitabine, cisplatin
- Keywords
- Resected advanced gastric cancer stage IIIB and IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel, capecitabine, cisplatinDrug
Also called docetaxel,xeloda,cisplatin
Docetaxel 60 mg/m2 IV (day 1) every 21 days capecitabine 1,875 mg/m2/day PO, divided two (day 1-day14) every 21 days Cisplatin 60 mg/m2 IV (day 1) every 21 days
| Study group | Role | What they receive |
|---|---|---|
| DXP | Experimental | Not described Receives: Drug: docetaxel, capecitabine, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
This protocol will evaluate the possible benefit of adjuvant docetaxel, capecitabine, and cisplatin combination chemotherapy in patients with resected gastric cancer pathologic stage IIIB and IV in terms of relapse free survival.
Measured: 5 years
Secondary outcomes (1)
Investigate the safety profiles, patient tolerance, and overall survival in this population
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startMay 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resected Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoon-Koo Kang, Asan Medical Center
- Investigators
- Yoon-Koo Kang, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976976
- Sponsor's protocol ID
- AMC0604
- Status last verified
- Jan 2020
- First submitted
- 14 Sep 2009
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00976976
- Acronym / sponsor ID
- AMC0604
- Conditions
- Resected Advanced Gastric Cancer
- Keywords
- Resected advanced gastric cancer stage IIIB and IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Sep 2009 (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.
Despite the improvement of surgical resection as primary curative treatment for gastric cancer, more than 70% of patients with stage IIIB and IV disease undergoing radical primary tumor resection relapse and die within 5 years. Therefore, there is an urgent need to further improve the treatment for gastric cancer in this population. Recently reported phase III study comparing capecitabine/cisplatin (XP) versus 5-FU/cisplatin (FP), XP showed better activity and tolerability compared with FP. To improve treatment outcomes of XP chemotherapy, the investigators performed a phase I-II study of docetaxel, capecitabine and cisplatin in advanced gastric cancer (AGC). Phase I-II study of docetaxel, capecitabine and cisplatin as first-line chemotherapy in advanced gastric cancer (Kang et al, Proc Am Soc Clin Oncol 22,328.2003). The docetaxel/capecitabine/cisplatin (DXP) chemotherapy was highly active for the 1st-line chemotherapy of AGC. These findings and experience encourages the investigators to design the adjuvant trial of DXP chemotherapy in patients with resected gastric cancer. The aim of this study is to assess the efficacy and safety of adjuvant DXP in this patient population.
Detailed description
Previous in phase II study of docetaxel, capecitabine and cisplatin,total 40 pts with measurable disease, median 6 cycles of chemotherapy, there were 4 confirmed complete responses (CRs) and 23 confirmed partial responses (PRs), with the overall response rate of 67.5% (95% confidence interval, 52.7 ~ 82.3) in intention-to-treat analysis. Ten patients underwent surgical resection after 4 ~ 9 cycles of chemotherapy. Four pathologic CRs were identified. With a median follow-up of 14 months (range, 1 to 28), median time to progression was 7.7 months, and median overall survival was 16.9 months. The DXP chemotherapy was highly active for the 1st-line chemotherapy of AGC (Kang et al, Proc Am Soc Clin Oncol 22,328.2003).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DXP | Experimental | Drug: docetaxel, capecitabine, cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically documented gastric adenocarcinoma
- Age 18 -70
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Pathologic stage IIIB or IV
- complete resection (R0 resection)
Key exclusion criteria (6 listed)
- Other tumor type than adenocarcinoma
- R1 or R2 resection
- Presence of distant metastasis
- Gastric outlet obstruction or intestinal obstruction
- Evidence of gastrointestinal bleeding
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 |
|---|---|---|
| docetaxel, capecitabine, cisplatinAlso: docetaxel,xeloda,cisplatinDocetaxel 60 mg/m2 IV (day 1) every 21 days capecitabine 1,875 mg/m2/day PO, divided two (day 1-day14) every 21 days Cisplatin 60 mg/m2 IV (day 1) every 21 days | Drug | DXP |
Primary outcome
This protocol will evaluate the possible benefit of adjuvant docetaxel, capecitabine, and cisplatin combination chemotherapy in patients with resected gastric cancer pathologic stage IIIB and IV in terms of relapse free survival.
Time frame: 5 years
1 secondary outcome
Investigate the safety profiles, patient tolerance, and overall survival in this population
Time frame: 5 years
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 7 Jan 2020.
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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.
Yoon-Koo Kang, MD, PhD principal investigator
Asan Medical Center
1 site 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, capecitabine, cisplatin in people with Resected Advanced Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
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 5 inclusion and 6 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
This protocol will evaluate the possible benefit of adjuvant docetaxel, capecitabine, and cisplatin combination chemotherapy in patients with resected gastric cancer pathologic stage IIIB and IV in terms of relapse free survival. (time frame: 5 years). 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 7 Jan 2020.