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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]


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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]


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.

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.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival (DFS)

Outcome Time Frame:

assessed up every 3 and 6 months after randomization, every 6 months for the fist three years and yearly afterward

Safety Issue:

No

Principal Investigator

Cecile Le Pechoux, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

CDR0000523568

NCT ID:

NCT00410683

Start Date:

February 2007

Completion Date:

February 2022

Related Keywords:

  • Non-Small Cell Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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