A Phase II Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors: Initial Report of Japan Clinical Oncology Group Trial (JCOG 9806)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pulmonary Neoplasm
- Sponsor
- Japan Clinical Oncology Group
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- 3-year survival rate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
3-year survival rate
Secondary Outcomes
- post-surgical morbidity/mortality
- local control rate
- complete resection rate