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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Resected Advanced Gastric Cancer

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Yoon-Koo Kang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

AMC0603

NCT ID:

NCT00976976

Start Date:

May 2007

Completion Date:

September 2011

Related Keywords:

  • Resected Advanced Gastric Cancer
  • Resected advanced gastric cancer stage IIIB and IV
  • Stomach Neoplasms

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