Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005724

Trial Description

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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]

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Trial Acronym

LUNG ART

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00005724
  •   2014/06/16
  •   2006/12/11
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT00410683  (ClinicalTrials.gov)
  •   CDR0000523568  (Gustave Roussy, Cancer Campus, Grand Paris)
  •   2006/1202 
  •   PROTEGE-01/0601 
  •   20671 
  •   05-03 
  •   UK11/NW/0075 
  •   22055-08053 
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Health Condition or Problem studied

  •   Non-small Cell Lung Cancer
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Other: clinical observation
  •   Procedure: adjuvant therapy
  •   Radiation: 3-dimensional conformal radiation therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- 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

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Secondary Outcome

- 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
- Local control; time frame: assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event
- Patterns of failure; time frame: assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event
- Overall survival (OS); time frame: assessed up In case of death whatever the cause
- Second cancers; time frame: Assessed up in case of event
- Prognostic and predictive factors of treatment effect on DFS and OS; time frame: assessed up at the end of the study
- Cost per recurrence-free year of life; time frame: Assessed up at the end of the study

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Countries of Recruitment

  •   France
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Locations of Recruitment

  • [---]*
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Recruitment

  •   [---]*
  •   2007/02/27
  •   700
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion 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.

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Exclusion Criteria

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.

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Addresses

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    • Gustave Roussy, Cancer Campus, Grand Paris
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    •   [---]*
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    • Intergroupe Francophone de Cancerologie Thoracique
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    •   [---]*
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    • Christie Hospital NHS Foundation Trust
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    •   [---]*
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    • European Organisation for Research and Treatment of Cancer - EORTC
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    •   [---]*
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    • Gustave Roussy, Cancer Campus, Grand Paris
    • Cecile Le Pechoux, MD 
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    •   [---]*
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    • Cécile LE PECHOUX, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/02/05
* This entry means the parameter is not applicable or has not been set.