Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer: Adjuvant DXP

• ClinicalTrials.gov Identifier: NCT00976976
• Recruitment Status: Completed
• First Posted: September 15, 2009
• Last Update Posted: January 7, 2020
• Sponsor: Asan Medical Center
• Information provided by (Responsible Party): Yoon-Koo Kang, Asan Medical Center

Tracking Information

• First Submitted Date: September 14, 2009
• First Posted Date: September 15, 2009
• Last Update Posted Date: January 7, 2020
• Study Start Date: May 2007
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 14, 2009): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 14, 2009): Investigate the safety profiles, patient tolerance, and overall survival in this population [ Time Frame: 5 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer: Adjuvant DXP
• Official Title: Phase 2 Study of Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer
• Brief 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. 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Resected Advanced Gastric Cancer

Intervention

Drug: docetaxel, capecitabine, 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

Other Name: docetaxel,xeloda,cisplatin

Study Arms

Experimental: DXP

Intervention: Drug: docetaxel, capecitabine, cisplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 14, 2009): 46
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00976976
• Other Study ID Numbers: AMC0604
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yoon-Koo Kang, Asan Medical Center
• Study Sponsor: Asan Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yoon-Koo Kang, MD, PhD; Asan Medical Center

• PRS Account: Asan Medical Center
• Verification Date: January 2020