Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): a Phase I/II Trial of Radiation Dose Escalation and Fixed Dose Chemotherapy.
1. Informed consent is required.
2. Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell
carcinoma, large cell carcinoma or a combination of these)
3. Patients must have a stage III unresectable LA-NSCLC:
4. Males or females aged between 18 and 75 years.
5. Life expectancy of at least 12 weeks.
6. ECOG performance status 0,1 or2.
7. Weight loss ≤ 10% within the last 3 months.
8. Laboratory requirements at entry:
• Blood cell counts: i. Absolute neutrophils ≥ 2.0 x 109/L ii. Platelets ≥ 100 x
109/L iii. Haemoglobin ≥ 11 g/dl
• Renal function: i. Serum creatinine < 1 x the upper limit of normal (UNL). ii. In
case of borderline value of serum creatinine, the 24h creatinine clearance should be
> 60 ml/min.
• Hepatic function: i. Serum bilirubin < 1 x UNL ii. ASAT and ALAT < 2.5 x UNL iii.
alkaline phosphatase < 5 x UNL iv. Patient with ASAT and/or ALAT > 1.5 x UNL
associated with alkaline phosphatase> 2.5 x UNL is not eligible for the study.
9. Lung function tests at entry:
- FEV1: ≥ 50 % x Normal value
- DLCO: ≥ 50 % x Normal value
10. Adequate cardiac function.
11. Patient with either measurable and/or non-measurable lesion (according to RECIST
1. Diagnosis of small cell lung cancer.
2. Stage IIIB NSCLC, based on the presence of malignant pleural or pericardial effusion.
3. Pregnant or lactating women.
4. Patients (male or female) with reproductive potential not implementing adequate
5. Prior systemic chemotherapy, immunotherapy, or biological therapy including
neoadjuvant or adjuvant treatment for NSCLC.
6. Prior surgery for NSCLC, if less than 5 years from study.
7. Prior radiotherapy for NSCLC.
8. History of prior malignancy, except for cured non-melanoma skin cancer, curatively
treated in-situ carcinoma of the cervix or other cancer curatively treated and with
no evidence of disease for at least five years.
9. Symptomatic peripheral neuropathy Grade ≥ 2 except if due to trauma.
10. Other serious concomitant illness or medical conditions:
11. Congestive heart failure or angina pectoris except if it is medically controlled.
Previous history of myocardial infarction within 1 year from study entry,
uncontrolled hypertension or arrhythmias.
12. History of significant neurological or psychiatric disorders including dementia or
13. Active infection requiring IV antibiotics.
14. Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid
15. Superior vena cava syndrome contra-indicating hydration.
16. Pre-existing pericardial effusion.
17. Pre-existing symptomatic pleural effusion.
18. Significant gastrointestinal abnormalities, including requirement for intravenous
nutrition, active peptic ulcer disease, prior surgical procedures affecting
19. Distant metastasis.
20. Concurrent treatment with any other experimental anti-cancer drugs.
21. Concomitant or within 4-week period administration of any other experimental drug
22. Significant ophthalmologic abnormalities.
23. Moderate to severe dermatitis.
24. Hypersensitivity to docetaxel, cisplatin, or any of its excipients.
25. Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
26. Mental condition rendering the patient unable to understand the nature, scope, and
possible consequences of the study.
27. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to
return for follow-up visits, and not likely to complete the study.