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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2006-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pulmonary Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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mitomycin C, vindesine, cisplatin and radiotherapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No