Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2011 Aug;14(3):212-8.
doi: 10.1007/s10120-011-0027-3. Epub 2011 Feb 19.

Randomized Clinical Trial of Adjuvant Chemotherapy With Intraperitoneal and Intravenous Cisplatin Followed by Oral Fluorouracil (UFT) in Serosa-Positive Gastric Cancer Versus Curative Resection Alone: Final Results of the Japan Clinical Oncology Group Trial JCOG9206-2

Affiliations
Clinical Trial

Randomized Clinical Trial of Adjuvant Chemotherapy With Intraperitoneal and Intravenous Cisplatin Followed by Oral Fluorouracil (UFT) in Serosa-Positive Gastric Cancer Versus Curative Resection Alone: Final Results of the Japan Clinical Oncology Group Trial JCOG9206-2

Isao Miyashiro et al. Gastric Cancer. .

Abstract

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-positive gastric cancer, a multicenter phase III clinical trial was conducted in Japan.

Patients and methods: From January 1993 to March 1998, 268 patients were randomized to adjuvant chemotherapy (135 patients) or surgery alone (133 patients). All patients underwent gastrectomy with D2 or greater lymph node dissection. The chemotherapy regimen consisted of intraperitoneal cisplatin soon after abdominal closure, postoperative intravenous cisplatin (day 14) and 5-fluorouracil (day 14-16), and daily oral FU (UFT) starting 4 weeks after surgery for 12 months. The primary endpoint was overall survival. Relapse-free survival and site of recurrence were secondary endpoints.

Results: Fifty-two patients (38.5%) in the adjuvant chemotherapy arm completed the chemotherapy regimen. There were 4 (1.49%) treatment-related deaths, 1 in the surgery-alone and 3 in the adjuvant chemotherapy arm (2 did not receive chemotherapy). Grade 4 toxicity was observed in 3 patients in the surgery-alone and 2 patients in the adjuvant chemotherapy arm. There was no significant difference in 5-year overall survival (62.0% adjuvant chemotherapy vs. 60.9% surgery-alone, P = 0.482) and 5-year relapse-free survival rates (57.5% adjuvant chemotherapy vs. 55.6% surgery-alone; P = 0.512).

Conclusion: There was no benefit in overall and relapse-free survival with this adjuvant chemotherapy regimen for patients with macroscopically serosa-positive gastric cancer after curative resection.

Trial registration: ClinicalTrials.gov NCT00147147.

Comment in

Similar articles

See all similar articles

Cited by 21 articles

See all "Cited by" articles

References

    1. J Clin Oncol. 2003 Jun 15;21(12):2282-7 - PubMed
    1. Ann Surg. 1993 Nov;218(5):583-92 - PubMed
    1. Jpn J Clin Oncol. 1993 Aug;23(4):250-7 - PubMed
    1. Gastric Cancer. 2002;5(1):1-5 - PubMed
    1. Gan To Kagaku Ryoho. 1995 Apr;22(5):703-8 - PubMed

MeSH terms

Associated data

Feedback