Hypofractionated Accelerated Radiotherapy With Concomitant Chemotherapy for NSCLC

This is a phase I/II trial on concomitant RT-full dose CHT using accelerated hypofractionation schedule as currently being in routine use in Poland for sequential combination or RT alone. Objectives of the study are: to estimate rate of grade ≥ 3 CTCAE adverse effects related to treatment and to estimate tumor control, progression free-survival, and overall survival in patients treated with this regimen. Stage III NSCLC patients are treated according to the following schedule: RT: 58.8 Gy in 21 fractions (2.8 Gy/fraction, 5 times a week, 6 times in the third week; CHT concomitant with RT (2 cycle of Cisplatinum and Vinorelbine, every 21 days). Feasibility of the studied approach is evaluated by scoring the toxicity during RT-CHT and therafter, as well as percentage of treatment completion; efficacity is evaluated by estimation of local control and survival. If toxicity and efficacity are similar or better than those observed in modern series of conventionally fractionated RT-CHT, the studied regimen will become a routine treatment schedule in our institution in order to spare RT resources. In the future, a randomized comparison of the studied schedule with conventionally fractionated RT-CHT for locally advanced NSCLC is also planned.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

* • Pathological or cytological confirmation of the diagnosis of NSCLC

  * Confirmation of clinical stage III based on: clinical examination, CT of the chest and abdomen (PET-CT highly recommended), bronchoscopy, CT or MRI of the brain if suspicion of brain metastases
  * No abnormalities in blood count precluding administration of full doses of Cisplatin and Vinorelbine (Neutrophils ≥1.5x109/L; Platelets ≥100 x109/L; Hemoglobin \>11 g/dl)
  * No abnormalities in renal and hepatic function precluding administration of full doses of Cisplatin and Vinorelbine (creatinine clearance \>50 ml/minute, aminotransferases \< 1.5 of upper limit of normal value)
  * Age \<75
  * KPS: 80-100
  * FEV1 \> 1 liter (except cases with very low body surface, when FEV1 should be \>40%)
  * No chronic diseases causing contraindication to the use of CHT
  * No previous RT on the thoracic region
  * Informed consent of patient for the participation in the study

Exclusion Criteria:

* Lack of meeting all inclusion criteria
* Presence of clinically examined supraclavicular lymph nodes
* Malignant pleural or pericardial effusion