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Completed

NCT Number: NCT00128037

Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (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.

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Key information

Age range

15 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center

Chuo-ku, Tokyo, 104-0045, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mitomycin C, vindesine, cisplatin and radiotherapy

Drug

Primary outcomes

  1. 3-year survival rate

Secondary outcomes

  1. complete resection rate

  2. post-surgical morbidity/mortality

  3. local control rate

Sponsors and collaborators

Lead sponsor

Japan Clinical Oncology Group

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study 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)

Important dates

Study start
1999
Study completion
2006
First posted
Aug 9, 2005
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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