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

Centre Antoine Lacassagne

Status

Completed

Conditions

Lung Cancer

Treatments

Device: CK

Study type

Interventional

Funder types

Other

Identifiers

NCT00945451

INCA-RECF0941

CDR0000639362

2008-A01104-51

CALACASS-CYBERTAXCIS

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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