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

Japan Clinical Oncology Group

Status and phase: Completed; Phase 2

Conditions: Pulmonary Neoplasm

Treatments: Drug: mitomycin C, vindesine, cisplatin and radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00128037

C000000031

JCOG 9806

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 15 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)