Status:
COMPLETED
Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Pulmonary Neoplasm
Eligibility:
All Genders
15-74 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.
Detailed Description
Pre-operative radiotherapy has long been the community standard in Pancoast, or superior sulcus tumor. However, both complete resection rate (-50%) and long-term survival (-30%) are poor and unchanged...
Eligibility Criteria
Inclusion
- Newly diagnosed, pathologically documented non-small cell lung cancer (NSCLC)
- Invasion to the first rib or more superior chest wall
- Age: 15-74 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Ample organ function
- No prior chemo- or radiotherapy
- Signed informed consent
Exclusion
- Metastasis to, or involvement of, mediastinal node (N2)
- Distant metastasis or dissemination to pleura/pericardium
- Active concomitant malignancy
- Unstable angina, recent myocardial infarction, heart failure
- Uncontrolled diabetes or hypertension
- Pregnant or lactating women
- Other severe complications
Key Trial Info
Start Date :
May 1 1999
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00128037
Start Date
May 1 1999
End Date
February 1 2006
Last Update
September 22 2016
Active Locations (1)
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1
National Cancer Center
Chuo-ku, Tokyo, Japan, 104-0045