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

Pulmonary Neoplasm Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128037
• Other study ID #: JCOG 9806
• Secondary ID: C000000031
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2005
• Last updated: September 20, 2016
• Start date: May 1999
• Est. completion date: February 2006

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 74 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Pulmonary Neoplasm

Intervention

Drug:
• mitomycin C, vindesine, cisplatin and radiotherapy

Locations

Country	Name	City	State
Japan	National Cancer Center	Chuo-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year survival rate
Secondary	complete resection rate
Secondary	post-surgical morbidity/mortality
Secondary	local control rate

External Links

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