Radiation Therapy in Treating Patients With Non Small Cell Lung Cancer That Has Been Completely Removed by Surgery (LUNG ART)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Collaborators:
Intergroupe Francophone de Cancerologie Thoracique
Christie Hospital NHS Foundation Trust
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00410683
First received: December 11, 2006
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy after surgery is more effective than no radiation therapy in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no radiation therapy in treating patients with non-small cell lung cancer that has been completely removed by surgery.


Condition Intervention Phase
Non-small Cell Lung Cancer
Other: clinical observation
Procedure: adjuvant therapy
Radiation: 3-dimensional conformal radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study Comparing Post-Operative Conformal Radiotherapy to No Post-Operative Radiotherapy in Patients With Completely Resected Non-Small Cell Lung Cancer and Mediastinal N2 Involvement [Lung ART]

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: assessed up every 3 and 6 months after randomization, every 6 months for the fist three years and yearly afterward ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute and late toxicity (with identification of predictive factors of toxicity) [ Time Frame: assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event ] [ Designated as safety issue: Yes ]
  • Local control [ Time Frame: assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event ] [ Designated as safety issue: No ]
  • Patterns of failure [ Time Frame: assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: assessed up In case of death whatever the cause ] [ Designated as safety issue: No ]
  • Second cancers [ Time Frame: Assessed up in case of event ] [ Designated as safety issue: No ]
  • Prognostic and predictive factors of treatment effect on DFS and OS [ Time Frame: assessed up at the end of the study ] [ Designated as safety issue: No ]
  • Cost per recurrence-free year of life [ Time Frame: Assessed up at the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: February 2007
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiotherapy
Beginning within 4-8 weeks after surgery or 2-6 weeks after chemotherapy, patients undergo adjuvant thoracic conformal radiotherapy once daily, 5 days per week, for 6 weeks.
Other: clinical observation Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy
Active Comparator: No radiotherapy
Patients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to 10 years.
Other: clinical observation Procedure: adjuvant therapy

Detailed Description:

OBJECTIVES:

Primary

  • Compare the disease-free survival of patients with completely resected non-small cell lung cancer treated with conformal thoracic radiotherapy vs no radiotherapy.

Secondary

  • Determine the toxicity, in particular cardiac and pulmonary toxicity, of these regimens in these patients.
  • Compare the local control in patients treated with these regimens.
  • Determine patterns of recurrence in patients treated with these regimens.
  • Determine the overall survival of patients treated with these regimens.
  • Assess second cancers in patients treated with these regimens.
  • Assess prognostic factors and predictive factors of treatment effect on disease-free survival and overall survival of patients treated with these regimens.
  • Determine the cost per recurrence-free year of life.

OUTLINE: This is a multicenter, randomized study.

Patients are stratified according to participating center, prior chemotherapy (neoadjuvant alone vs adjuvant vs none), number of lymph stations involved (0 vs 1 vs ≥ 2), histology (squamous cell vs other), and use of pretreatment positron emission tomography scans (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Beginning within 4-8 weeks after surgery or 2-6 weeks after chemotherapy, patients undergo adjuvant thoracic conformal radiotherapy once daily, 5 days per week, for 6 weeks.
  • Arm II: Patients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to10 years.

PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA :

  1. Histological evidence of non-small cell lung cancer (NSCLC),
  2. Complete resection by lobectomy, bilobectomy or pneumonectomy (i.e patients with positive margins or extra-capsular extension in a node removed separately in case of sampling not to be included)
  3. Mediastinal lymph node exploration (lymph node sampling or systematic dissection of lymph nodes at levels 2, 4 and 7 in case of upper/middle right-sided lung cancer; 4, 7, 8 and 9 in case of lower right-sided lung cancer; 5, 6 and 7 in case of upper left -sided lung cancer; 7, 8 and 9 in case of lower left-sided lung cancer is recommended
  4. Pathologically or cytologically documented N2 mediastinal nodal involvement, at the time of surgery if no preoperative chemotherapy or before preoperative chemotherapy, according to the criteria of the joint AJCC and UICC classification, clinical N2 patients without cytological or histological documentation of mediastinal node involvement before preoperative chemotherapy can be included in the study if and only if, they have histologically confirmed N2 disease at the time of surgery.
  5. Prior chemotherapy is allowed (pre-operative or post-operative adjuvant chemotherapy, or both),
  6. Patient aged >=18 years,
  7. Good Performance status (WHO * 1)
  8. Adequate pulmonary function with post-operative FEV1 after surgery > 1 l or over 35% theoretical value, PO2 >= 70 mmHg, PCO2 < 45 mmHg,
  9. Signed informed consent form.

EXCLUSION CRITERIA:

  1. Documented metastases, (except for ipsilateral nodule(s) in a different lobe after pneumonectomy or bi-lobectomy).
  2. Major pleural or pericardial effusion,
  3. Synchronous contra-lateral lung cancer,
  4. Clinical progression during post-operative chemotherapy,
  5. Previous chest radiotherapy
  6. Intention of concomitant chemotherapy during radiotherapy
  7. Weight loss in the previous 6 months before surgery >= 10%
  8. Evidence of severe or uncontrolled systemic disease as judged by the investigator
  9. Recent (< 6 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease
  10. Current or past history of neoplasm other than non-small cell lung cancer diagnosed within the last 5 years, except :

    • basal cell carcinoma of the skin,
    • in situ carcinoma of the cervix A patient diagnosed for another neoplasm 5 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected.
  11. Pregnancy or breast feeding or inadequate contraceptive measures during treatment,
  12. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls,
  13. Patient deprived of freedom or under guardianship.
  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: NCT00410683

Contacts
Contact: Cécile LE PECHOUX, MD 0142114757 ext +33 cecile.lepechoux@igr.fr
Contact: Ariane DUNANT, PhD 0142115389 ext +33 ariane.dunant@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Cecile Le Pechoux, MD    0142114757 ext +33    cecile.lepechoux@igr.fr   
Contact: Ariane Dunant, PhD    0142115389 ext +33    ariane.dunant@igr.fr   
Principal Investigator: Cécile LE PECHOUX, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Intergroupe Francophone de Cancerologie Thoracique
Christie Hospital NHS Foundation Trust
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Cecile Le Pechoux, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00410683     History of Changes
Other Study ID Numbers: CDR0000523568, 2006/1202, PROTEGE-01/0601, 20671, IFCT - 0503, UK11/NW/0075, 22055-08053
Study First Received: December 11, 2006
Last Updated: February 10, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

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

ClinicalTrials.gov processed this record on August 25, 2014