Stereotactic Radiosurgery in Treating Patients Undergoing Chemotherapy and Radiation Therapy For Stage III Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CK
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage II non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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
Sites / Locations
- Centre Antoine Lacassagne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CyberKnife irradiation
Arm Description
Outcomes
Primary Outcome Measures
Maximum tolerated dose (phase I)
Overall response rate by RECIST (phase II)
Secondary Outcome Measures
Full Information
NCT ID
NCT00945451
First Posted
July 23, 2009
Last Updated
September 13, 2019
Sponsor
Centre Antoine Lacassagne
1. Study Identification
Unique Protocol Identification Number
NCT00945451
Brief Title
Stereotactic Radiosurgery in Treating Patients Undergoing Chemotherapy and Radiation Therapy For Stage III Non-Small Cell Lung Cancer
Official Title
Study of Doses Escalation on Efficacy on Cyberknife After Docetaxel-Cisplatin Concomitant Radiotherapy for Non Small Cells Lung Cancer Stage III
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 24, 2009 (Actual)
Primary Completion Date
November 17, 2016 (Actual)
Study Completion Date
November 17, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
OBJECTIVES:
Primary
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)
Secondary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage II non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CyberKnife irradiation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CK
Intervention Description
Cyberknife Irradiation
Primary Outcome Measure Information:
Title
Maximum tolerated dose (phase I)
Time Frame
5 years
Title
Overall response rate by RECIST (phase II)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
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
PRIOR CONCURRENT THERAPY:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves Bondiau, MD, PhD
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
12. IPD Sharing Statement
Learn more about this trial
Stereotactic Radiosurgery in Treating Patients Undergoing Chemotherapy and Radiation Therapy For Stage III Non-Small Cell Lung Cancer
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