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)
15 Years
74 Years
Both
Pulmonary Neoplasm
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3-year survival rate
Principal Investigator
Harubumi Kato, M.D., Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Tokyo Medical University
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JCOG 9806
NCT ID:
NCT00128037
Start Date:
May 1999
Completion Date:
February 2006
Related Keywords:
- Pulmonary Neoplasm
- pulmonary neoplasm
- preoperative chemoradiotherapy
- surgical resection
- superior sulcus tumor
- chest wall invasion
- mytomicin C
- vindesine
- cisplatin
- Neoplasms
- Lung Neoplasms
- Pancoast Syndrome
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