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

This study is currently recruiting participants.
Verified October 2013 by Centre Henri Becquerel
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel
ClinicalTrials.gov Identifier:
NCT01576796
First received: April 11, 2012
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Stage III Non-small-cell Lung Cancer
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Henri Becquerel:

Primary Outcome Measures:
  • Evaluate the rate of local control [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    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:
  • 3 months and 1 year toxicity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    3 months and 1 year toxicity measured according CTCAE 4.0

  • Percentage of patients for whom the RT dose could be increased [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Percentage of patients for whom the RT dose could be increased

  • Simultaneous variation of the glucose metabolism and hypoxia during radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    comparaison of both exam PETscan FDG and PETscan FMISO performed during radiotherapy

  • Predictive value on 1-year survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Predictive value on 1-year survival probability of the variations in glucose metabolism and hypoxia during radiotherapy


Estimated Enrollment: 75
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576796

Contacts
Contact: Pierre VERA, university professor 232082497 ext 33 pierre.vera@chb.unicancer.fr
Contact: Olivier RASTELLI, study coordinator 232082900 ext 33 olivier.rastelli@chb.unicancer.fr

Locations
France
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Principal Investigator: Pierre VERA, PhD- HP         
Sub-Investigator: Agathe Edet-Sanson, HP         
Sub-Investigator: bernard DUBRAY, pHD - HP         
Sub-Investigator: Sebastien THUREAUX, HP         
Sponsors and Collaborators
Centre Henri Becquerel
  More Information

No publications provided

Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT01576796     History of Changes
Other Study ID Numbers: CHB11-01
Study First Received: April 11, 2012
Last Updated: October 30, 2013
Health Authority: France: Committee for the Protection of Personnes

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Complement System Proteins
Fluoromisonidazole
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014