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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00128037

Enrollment

Registered

2005-08-09

Start date

1999-05-31

Completion date

2006-02-28

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Neoplasm

Keywords

pulmonary neoplasm, preoperative chemoradiotherapy, surgical resection, superior sulcus tumor, chest wall invasion, mytomicin C, vindesine, cisplatin

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.

Interventions

DRUGmitomycin C, vindesine, cisplatin and radiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 74 Years

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

Design outcomes

Primary

Measure	Time frame
3-year survival rate	—

Secondary

Measure	Time frame
complete resection rate	—
post-surgical morbidity/mortality	—
local control rate	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026