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NCT Number: NCT00976976

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

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.

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Key information

Conditions

Resected Advanced Gastric Cancer

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel, capecitabine, cisplatin

Drug

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 names: docetaxel,xeloda,cisplatin

Primary outcomes

  1. 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

Secondary outcomes

  1. Investigate the safety profiles, patient tolerance, and overall survival in this population

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Phase 2 Study of Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2009
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.