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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

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

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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)

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

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

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

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