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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00128037
First received: August 8, 2005
Last updated: March 5, 2007
Last verified: March 2007

August 8, 2005
March 5, 2007
May 1999
Not Provided
3-year survival rate
Same as current
Complete list of historical versions of study NCT00128037 on ClinicalTrials.gov Archive Site
  • complete resection rate
  • post-surgical morbidity/mortality
  • local control rate
Same as current
Not Provided
Not Provided
 
Trial of Pre-Operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)
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)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Neoplasm
Drug: mitomycin C, vindesine, cisplatin and radiotherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
February 2006
Not Provided

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
Both
15 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00128037
JCOG 9806, C000000031
Not Provided
Not Provided
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Harubumi Kato, M.D., Ph.D. Tokyo Medical University
Japan Clinical Oncology Group
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP