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Completed

NCT Number: NCT00238875

A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)

To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer

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Key information

Conditions

T1N0M0 Non-small Cell Lung Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyushu University Hospital, Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan

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About this study

To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer，the following questions should be answered. Can SRT be an alternative standard treatment modality for inoperable patients? Can SRT can be a comparable standard treatment modality with lobectomy for operable patients? 12 Gy is the daily dose at the isocenter，and 48 Gy in total by 4 fractions will be irradiated by stereotactic irradiation over 4 to 8 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer
  • Stage IA with images within 28 days
  • No other intrathoracic lesions
  • Dose constraints of the organs at risk seem to be limited within range
  • Operable (Standard or Limited surgery) or Inoperable
  • Age>=20
  • No previous thoracic radiation
  • No previous chemotherapy
  • ECOG PS=0-2
  • Respiratory function (<=14 days) PaO2>=60 torr FEV1.0>=700 ml
  • Written informed consent

Exclusion criteria

  • No apparent radiation pneumonitis and fibrosis
  • No active tuberculosis without oral drugs
  • No double cancer
  • No pregnancy
  • No psychiatric disorder
  • No steroid administration

Treatment and study plan

stereotactic body radiation therapy

Procedure

Procedure/Surgery: stereotactic body radiation therapy

Primary outcomes

  1. 3-years overall survival

    Time frame: During the study conduct

Secondary outcomes

  1. Overall survival

    Time frame: During the study conduct

  2. relapse-free survival

    Time frame: During the study conduct

  3. local-relapse free survival

    Time frame: During the study conduct

  4. 3-years local relapse free survival

    Time frame: During the study conduct

  5. patterns of relapse

    Time frame: During the study conduct

  6. acute complications

    Time frame: within 8 weeks from starting treatment day

  7. late complications

    Time frame: after 8 weeks from starting treatment day

  8. serious complication rate

    Time frame: During the study conduct

Sponsors and collaborators

Lead sponsor

Haruhiko Fukuda

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2005
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.