Stereotactic Radiosurgery in Treating Patients Undergoing Chemotherapy and Radiation Therapy For Stage III Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00945451
Recruitment Status : Recruiting
First Posted : July 24, 2009
Last Update Posted : February 5, 2018
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well it works in treating patients with stage III non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: CK Not Applicable

Detailed Description:



  • Evaluate the maximum tolerated dose of stereotactic radiosurgery in patients with locally advanced non-small cell lung cancer undergoing concurrent chemoradiotherapy. (Phase I)
  • Assess the response rate (complete and partial response) in these patients by RECIST criteria. (Phase II)


  • Determine the tolerability. (Phase I)
  • Assess the quality of life of these patients by QLQ-C30 v3. (Phase I)
  • Assess the overall and disease-free survival of these patients. (Phase II)
  • Assess progression-free survival of these patients. (Phase II)

OUTLINE: This is a multicenter, phase I dose escalation study of stereotactic radiosurgery followed by a phase II study.

Patients receive docetaxel IV and cisplatin IV on days 1, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Beginning on day 43, patients undergo concurrent radiotherapy to the mediastinum 5 days a week. Beginning 2-3 weeks after chemoradiotherapy, patients undergo stereotactic radiosurgery on days 1, 3, and 5.

Quality of life is assessed by the QLQ-C30 v3 questionnaire at baseline, after radiosurgery, and at 6 and 12 months after completion of study treatment.

After completion of study treatment, patients are followed up monthly for 6 months, every 3 months for 1 year, and then every 6 months for 3 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Doses Escalation on Efficacy on Cyberknife After Docetaxel-Cisplatin Concomitant Radiotherapy for Non Small Cells Lung Cancer Stage III
Study Start Date : January 2009
Actual Primary Completion Date : November 17, 2016
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: CyberKnife irradiation Device: CK
Cyberknife Irradiation

Primary Outcome Measures :
  1. Maximum tolerated dose (phase I) [ Time Frame: 5 years ]
  2. Overall response rate by RECIST (phase II) [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed non-small cell lung cancer

    • Locally advanced disease
  • No metastatic disease
  • Unable to undergo surgery after concurrent chemoradiotherapy
  • Must have 1-3 tumor target masses < 5 cm in greatest diameter and separated by ≥ 2 cm after concurrent chemoradiotherapy


  • WHO performance status 0-2
  • Platelet count > 100,000/mm³
  • Hemoglobin > 9 g/dL
  • Neutrophil > 1.0 x 10^9/L
  • FEV_1 > 30% of vital capacity
  • Vital capacity > 25% of predicted value
  • DLCO > 25% of predicted value
  • LVEF ≥ 35%
  • PT > 80
  • aPTT > 35 sec
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • Not under guardianship
  • No dyspnea related to NYHA class III-IV heart failure
  • No indirect signs of pulmonary arterial hypertension (pulmonary arterial systolic BP > 45 mm Hg)
  • No pulmonary acceleration time < 100 ms
  • No contraindication to fiducial insertion
  • No geographical, social, or psychological conditions that would interfere with medical follow-up


  • Docetaxel and platinum-based drugs with concurrent irradiation allowed
  • No prior surgery or surgery after the first phase of treatment with concurrent chemoradiotherapy
  • No prior irradiation to lung
  • No concurrent participation in another study trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00945451

Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Pierre-Yves Bondiau, MD, PhD    33-4-9203-1261      
Sponsors and Collaborators
Centre Antoine Lacassagne
Principal Investigator: Pierre-Yves Bondiau, MD, PhD Centre Antoine Lacassagne

Responsible Party: Centre Antoine Lacassagne Identifier: NCT00945451     History of Changes
Other Study ID Numbers: CDR0000639362
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Centre Antoine Lacassagne:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage II non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms