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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Centre Antoine Lacassagne
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT00945451
First received: July 23, 2009
Last updated: November 20, 2014
Last verified: August 2012
  Purpose

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 Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: docetaxel
Procedure: quality-of-life assessment
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • Maximum tolerated dose (phase I) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Overall response rate by RECIST (phase II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyberKnife irradiation Drug: cisplatin Drug: docetaxel Procedure: quality-of-life assessment Radiation: radiation therapy
CyberKnife Radiation therapy
Radiation: stereotactic radiosurgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945451

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

Additional Information:
No publications provided

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT00945451     History of Changes
Other Study ID Numbers: CDR0000639362, CALACASS-CYBERTAXCIS, INCA-RECF0941, 2008-A01104-51
Study First Received: July 23, 2009
Last Updated: November 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014