Content - EORTC LungART

EORTC LungART - What benefits does additional irradiation offer in lung cancer (non-small-cell lung carcinoma (NSCLC) in stage N2)?

A study in collaboration with the EORTC (European Organisation for Research and Treatment of Cancer) and Gustave Roussy (European Cancer Centre in Paris).

Non-small-cell lung carcinoma in stage N2 (which means that metastases are present in the lymph nodes on the same side of the chest as the original tumor) is usually treated with surgery and chemotherapy before or after the operation. Even though the tumor is completely removed, there is still a possibility that it will recur in the chest region. It has been repeatedly found that, while additional postoperative irradiation of the chest area reduces the likelihood of a local recurrence, this does not improve survival prospects. Moreover, little is still known about the risk of side effects of this radiotherapy.

The aim of the “LungART” trial involving 700 patients in several European countries is therefore to establish whether and, if so, how postoperative irradiation affects survival prospects and what side effects occur. To this end, half the patients receive radiotherapy for six weeks after the operation, and the other half of patients do not receive any further treatment.

Study chair:

Dr. Cecile Le Pechoux, Gustave Roussy, Cancer Campus Grand Paris,

014 211 47 57

 

 

  • Principal Investigators

  • 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

Locations for this trial:

Fondazione Oncologia Lago Maggiore
Via Antonio Ciseri 19
0 6600 Locarno
Inselspital
Freiburgstrasse 8
3010 Bern
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Hôpitaux Universitaires de Genève HUG
Rue Gabrielle-Perret-Gentil 4
0 1205 Genève
Kantonsspital St. Gallen
Rorschacher Strasse 95
0 9007 St. Gallen
Kantonsspital Winterthur
Brauerstrasse 15
0 8401 Winterthur
UniversitätsSpital Zürich
Rämistrasse 100
0 8091 Zürich