LungArt EORTC Protokoll 22055-08053: Phase-III-Studie zum Vergleich zwischen postoperativer konformaler Strahlentherapie und nicht-postoperativer Strahlentherapie bei Patienten mit vollständig reseziertem nicht-kleinzelligen Lungenkarzinom und mediastinalem Lymphknotenbefall (N2)

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

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 mediastinal nodal extension breaching the surface
of the pathological specimen should not to be included

3. Mediastinal lymph node exploration (lymph node sampling or systematic dissection of
lymph nodes at stations 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 = 2)

8. Fit enough to receive curative radiotherapy

9. Adequate pulmonary function with post-operative FEV1 after surgery > 1 l or over 35%
theoretical value

10. 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