search
Back to results

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

Primary Purpose

Pulmonary Neoplasm

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
mitomycin C, vindesine, cisplatin and radiotherapy
Sponsored by
Japan Clinical Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Neoplasm focused on measuring pulmonary neoplasm, preoperative chemoradiotherapy, surgical resection, superior sulcus tumor, chest wall invasion, mytomicin C, vindesine, cisplatin

Eligibility Criteria

15 Years - 74 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center

Outcomes

Primary Outcome Measures

3-year survival rate

Secondary Outcome Measures

complete resection rate
post-surgical morbidity/mortality
local control rate

Full Information

First Posted
August 8, 2005
Last Updated
September 20, 2016
Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
search

1. Study Identification

Unique Protocol Identification Number
NCT00128037
Brief Title
Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Neoplasm
Keywords
pulmonary neoplasm, preoperative chemoradiotherapy, surgical resection, superior sulcus tumor, chest wall invasion, mytomicin C, vindesine, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
mitomycin C, vindesine, cisplatin and radiotherapy
Primary Outcome Measure Information:
Title
3-year survival rate
Secondary Outcome Measure Information:
Title
complete resection rate
Title
post-surgical morbidity/mortality
Title
local control rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harubumi Kato, M.D., Ph.D.
Organizational Affiliation
Tokyo Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Center
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.jcog.jp/
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs