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Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Patients With Stage III Non-small-cell Lung Cancer (RTEP-5)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01576796
Recruitment Status : Active, not recruiting
First Posted : April 12, 2012
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC not amenable to surgery and candidate for chemoradiotherapy.

Preliminary studies in head and neck cancers have demonstrated the feasibility and support the medical benefit of this novel approach.

The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement (boost) in this difficult medical condition for which only limited treatment options are available.


Condition or disease Intervention/treatment Phase
Stage III Non-small-cell Lung Cancer Radiation: Radiotherapy Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of the Efficacy and Safety of a Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Identified by F-miso PET/CT in Patients With Stage III Non-small-cell Lung Cancer (NSCLC) Not Amenable to Curative Surgical Resection Who Are Candidate for Curative Radio-chemotherapy
Study Start Date : March 2012
Primary Completion Date : March 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Radiation: Radiotherapy

    No additional dose (patients negative F-miso)

    • Radiation therapy is conducted under standard conditions of conformal radiotherapy:
    • The total dose was 66-70 Gy delivered in daily fractions of 2 Gy, 5 days a-week

    With additional dose (patients positive for F-miso)

    The dose in the PTVmiso increased until the maximum tolerable radiation by the lung.


Outcome Measures

Primary Outcome Measures :
  1. Evaluate the rate of local control [ Time Frame: 3 month ]
    to evaluate the rate of local control after dose complement in hypoxic lesions [maximum dose without the fraction of total lung volume receiving more that 20 Gy exceeding 30% of the lung (V20)], as determined by F-miso PET/CT.


Secondary Outcome Measures :
  1. 3 months and 1 year toxicity [ Time Frame: 1 year ]
    3 months and 1 year toxicity measured according CTCAE 4.0

  2. Percentage of patients for whom the RT dose could be increased [ Time Frame: 3 years ]
    Percentage of patients for whom the RT dose could be increased

  3. Simultaneous variation of the glucose metabolism and hypoxia during radiotherapy [ Time Frame: 3 years ]
    comparaison of both exam PETscan FDG and PETscan FMISO performed during radiotherapy

  4. Predictive value on 1-year survival [ Time Frame: 1 year ]
    Predictive value on 1-year survival probability of the variations in glucose metabolism and hypoxia during radiotherapy


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with stage III non-small-cell lung cancer candidate for curative radio-chemotherapy
  • The final inclusion is granted after completion of a dosimetric study confirming that the dose objectives (minimum dose of 60 Gy in 99% of target volume) and constraints to organs at risk can be achieved.

Exclusion Criteria:

  • Other cancer
  • no evaluable tumor target
  • Absence of binding to FDG-PET tests before primary chemotherapy
  • Patients for which radiotherapy with curative intent is not indicated
  • History of neoplastic disease of less than 5 years or progressive
  • Patient already included in another clinical trial
  • Pregnant, likely to be or during breastfeeding
  • performance index OMS ≥2
  • Indicating renal insufficiency against Cisplatin treatment
  • Protected adults
  • Unable to submit to medical study for reasons geographical, social or physical
  • Patients with poorly controlled diabetes blood sugar ≥10 mmol/L
  • hypersensitivity to FDG or any excipients of the radiopharmaceutical
  • hypersensitivity to Fmiso or any excipients of the radiopharmaceutical
  • Patients unable to understand the study (language ...)
  • Patients not affiliated to the "sécurité social"
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01576796


Locations
France
Centre Henri Becquerel
Rouen, France, 76000
Sponsors and Collaborators
Centre Henri Becquerel
More Information

Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT01576796     History of Changes
Other Study ID Numbers: CHB11-01
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Keywords provided by Centre Henri Becquerel:
Radiotherapy
Fmiso
FDG PETSCAN
FMISO PETSCAN
complement dose
lung cancer
NSCLC
hypoxic lesion

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Hypoxia
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Signs and Symptoms, Respiratory
Signs and Symptoms
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs