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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128037
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : September 22, 2016
Ministry of Health, Labour and Welfare, Japan
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Neoplasm Drug: mitomycin C, vindesine, cisplatin and radiotherapy Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 1999
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 3-year survival rate

Secondary Outcome Measures :
  1. complete resection rate
  2. post-surgical morbidity/mortality
  3. local control rate

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128037

National Cancer Center
Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Harubumi Kato, M.D., Ph.D. Tokyo Medical University

Additional Information: Identifier: NCT00128037     History of Changes
Other Study ID Numbers: JCOG 9806
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Japan Clinical Oncology Group:
pulmonary neoplasm
preoperative chemoradiotherapy
surgical resection
superior sulcus tumor
chest wall invasion
mytomicin C

Additional relevant MeSH terms:
Lung Neoplasms
Pancoast Syndrome
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators