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

• Sponsor: Japan Clinical Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00128037
• Collaborator: Ministry of Health, Labour and Welfare, Japan (Other)
• Enrollment: 75
• Location: 1
• Duration (Months): 81.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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 1, 1999
• Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

1. 3-year survival rate []

Secondary Outcome Measures

1. complete resection rate []

2. post-surgical morbidity/mortality []

3. local control rate []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 74 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00128037
• Other Study ID Numbers: JCOG 9806; C000000031
• First Posted: Aug 9, 2005
• Last Update Posted: Sep 22, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by , ,: pulmonary neoplasm; preoperative chemoradiotherapy; surgical resection; superior sulcus tumor; chest wall invasion; mytomicin C; vindesine; cisplatin
• Additional relevant MeSH terms: Lung Neoplasms; Pancoast Syndrome; Mitomycins; Mitomycin; Vindesine

Study Results

No Results Posted as of Sep 22, 2016