Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)

Phase 2

Completed

• Conditions: Pulmonary Neoplasm

• Registration Number: NCT00128037
• Lead Sponsor: Japan Clinical Oncology Group

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 for 40 years. Concurrent chemoradiotherapy has been shown to be beneficial in unresectable stage III non-small cell cancer. Surgery after induction chemoradiotherapy thus is a promising treatment strategy, and in fact, SWOG reported favorable results of this trimodality approach in superior sulcus tumor. The current trial is a Japanese, cooperative, multi-center, prospective one to evaluate its safety and efficacy.

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-09
• Study Completion: 2006-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
3-year survival rate

Secondary Outcome Measures

Name	Time	Method
post-surgical morbidity/mortality
local control rate
complete resection rate

Trial Locations

Locations (1)

National Cancer Center; 🇯🇵 Chuo-ku, Tokyo, Japan