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Standardization of Surgery on the Pancreatic Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Active 20 to 85 Other H-0509-513-157
NCT00679913

Trial Description

Summary

This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

Further Study Information

In Japan and in some western treatment centers, there has been a general belief that more extensive surgery may improve outcome for patients with localized, operable pancreatic adenocarcinoma. Initial retrospective reports from centers in Japan suggested that 5-year overall survival rates in patients treated with pancreaticoduodenectomy plus extended lymphadenectomy were higher than those in patients treated by pancreaticoduodenectomy with standard lymphadenectomy. Subsequent prospective randomized trials performed in Europe and the United States failed to confirm a survival benefit from extended lymphadenectomy. Although they failed to confirm a survival benefit from extended lymphadenectomy, the studies had a few pitfalls. The need for Well-designed randomised controlled study is the starting point of our study. This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

Eligibility Criteria

Inclusion Criteria:

Age : 20- 85 years old

No evidence of metastasis and to be possible to resect radically

No history of previous radiation therapy or chemotherapy

Pathological diagnosis: adenocarcinoma of pancreas

Patients who agree and sign the informed consent

More than 70 in Karnofsky performance scale

Exclusion Criteria:

Past medical history of treatment for other malignant disease

Recurred pancreatic cancer patients

Patients with R1/R2 resection

Patients who underwent neoadjuvant chemotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Seoul National University Hospital

Sun-Whe Kim, MD., PhD.

Principal Investigator

Sun-Whe Kim, MD., PhD.		Ph: 82-2-2072-2315
		Email: sunkim@plaza.snu.ac.kr

Jin-Young Jang, MD., PhD.		Ph: 82-2-2072-2194
		Email: jangjy4@snu.ac.kr

Trial Sites

Republic of Korea

Seoul

Seoul National University Hospital

Sun-Whe Kim, MD., PhD. Ph: 82-2-2072-2315

Email: sunkim@plaza.snu.ac.kr

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00679913
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.