- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00128037
Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)
September 20, 2016 updated by: Japan Clinical Oncology Group
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
75
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 74 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
3-year survival rate
|
Secondary Outcome Measures
Outcome Measure |
---|
complete resection rate
|
post-surgical morbidity/mortality
|
local control rate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Harubumi Kato, M.D., Ph.D., Tokyo Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 1999
Study Completion
February 1, 2006
Study Registration Dates
First Submitted
August 8, 2005
First Submitted That Met QC Criteria
August 8, 2005
First Posted (Estimate)
August 9, 2005
Study Record Updates
Last Update Posted (Estimate)
September 22, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Pancoast Syndrome
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Antibiotics, Antineoplastic
- Mitomycins
- Mitomycin
- Vindesine
Other Study ID Numbers
- JCOG 9806
- C000000031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Neoplasm
-
University of Colorado, DenverNational Cancer Institute (NCI); University of Kentucky; University of Louisville and other collaboratorsNot yet recruitingLung Cancer | Neoplasms, Lung | Pulmonary Neoplasms | Neoplasms, Pulmonary | Pulmonary Cancer | Cancer of Lung | Cancer, Lung | Cancer of the Lung | Pulmonary Neoplasm | Lung Cancers | Neoplasm, Pulmonary | Cancers, Lung | Cancer, Pulmonary | Cancers, Pulmonary | Pulmonary Cancers
-
University Hospital Southampton NHS Foundation...University College London Hospitals; The Leeds Teaching Hospitals NHS Trust; University... and other collaboratorsUnknown
-
University Hospital, RouenCompletedPulmonary Nodule Persistent | Malignant Neoplasm of the Respiratory System | Benign Neoplasms of the Respiratory SystemFrance
-
The First Affiliated Hospital of Guangzhou Medical...UnknownPulmonary Metastases | NSCLCChina
-
Ruijin HospitalRecruiting
-
Ruijin HospitalCompleted
-
Ruijin HospitalShanghai Futuo Zhida Medical Technology Co., LtdWithdrawn
-
Ruijin HospitalRecruitingAdvanced Cancer | Locally Advanced Cancer | Pulmonary NeoplasmChina
-
National Taiwan University HospitalWithdrawnPrimary and Secondary Pulmonary HypertensionTaiwan
-
Chang ChenCompletedLung Neoplasm | Thoracic Surgery, Video-AssistedChina
Clinical Trials on mitomycin C, vindesine, cisplatin and radiotherapy
-
National Cancer Institute (NCI)Unknown
-
University of Southern CaliforniaUnknownHepatocellular Carcinoma | Liver CancerUnited States
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Azienda Usl di BolognaCompletedColorectal Neoplasm | Metastasis
-
Guy's and St Thomas' NHS Foundation TrustUnknownPrimary Open Angle GlaucomaUnited Kingdom
-
Dermatologic Cooperative Oncology GroupUnknown
-
University of California, San DiegoCompletedOpen Angle Glaucoma
-
International Atomic Energy AgencyCompletedCervix CancerPeru, Korea, Republic of, Morocco, Austria, Brazil, Canada, India, Macedonia, The Former Yugoslav Republic of, Pakistan, South Africa, United Kingdom
-
European Organisation for Research and Treatment...Medical Research CouncilCompletedCervical CancerUnited Kingdom
-
European Organisation for Research and Treatment...TerminatedAnal CancerFrance, Belgium, Germany, Egypt, Serbia, Netherlands, Italy
-
Medical Enterprises Ltd.TerminatedUrinary Bladder Cancer | Bladder Cancer | Malignant Tumor of Urinary Bladder | Bladder Neoplasm | Cancer of Bladder | Carcinoma in Situ of Bladder | Bladder Tumors | Cancer of the Bladder | Neoplasms, Bladder | Papillary Carcinoma of Bladder (Diagnosis) | BCG-Unresponsive Bladder CancerUnited States