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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.

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Non-Small-Cell Lung Carcinoma

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Trial Information

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.

Dose escalation steps are:

30*2.00Gy = 60.0Gy (BED= 70.8Gy10 NID2= 60.0Gy) 30*2.12Gy = 63.6Gy (BED= 75.9Gy10 NID2=
64.2Gy) 30*2.24Gy = 67.2Gy (BED= 81.5Gy10 NID2= 68.5Gy) 30*2.36Gy = 70.8Gy (BED= 86.3Gy10
NID2= 72.9Gy) If MTD is not reached, protocol modification allowing further escalation can
be considered.

Inclusion Criteria:

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
criteria, A1).

Exclusion Criteria:

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
contraceptive measures.

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
under investigation.

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.

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the feasibility and toxicity of radiation dose escalation using helical tomotherapy concurrently with chemotherapy (docetaxel-cisplatin combination) in stage III locally advanced non small cell lung cancer (LA-NSCLC).

Principal Investigator

Samuel Bral, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:




Start Date:

November 2006

Completion Date:

April 2008

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • helical tomotherapy
  • dose escalation
  • chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms