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
  Purpose

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 Intervention Phase
Pulmonary Neoplasm
Drug: mitomycin C, vindesine, cisplatin and radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • 3-year survival rate

Secondary Outcome Measures:
  • complete resection rate
  • post-surgical morbidity/mortality
  • local control rate

Estimated Enrollment: 75
Study Start Date: May 1999
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   15 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128037

Locations
Japan
National Cancer Center
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Harubumi Kato, M.D., Ph.D. Tokyo Medical University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00128037     History of Changes
Other Study ID Numbers: JCOG 9806, C000000031
Study First Received: August 8, 2005
Last Updated: March 5, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Vindesine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014