Status:
UNKNOWN
Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
AZ-VUB
Collaborating Sponsors:
Sanofi
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This non-randomized Phase I/II study is designed to determine the maximum tolerated dose (MTD) of thoracic radiotherapy and concurrent chemotherapy with cisplatin and docetaxel in patients with LA-NSC...
Detailed Description
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=...
Eligibility Criteria
Inclusion
- Informed consent is required.
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
- Patients must have a stage III unresectable LA-NSCLC:
- Males or females aged between 18 and 75 years.
- Life expectancy of at least 12 weeks.
- ECOG performance status 0,1 or2.
- Weight loss ≤ 10% within the last 3 months.
- 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.
- Lung function tests at entry:
- FEV1: ≥ 50 % x Normal value
- DLCO: ≥ 50 % x Normal value
- Adequate cardiac function.
- Patient with either measurable and/or non-measurable lesion (according to RECIST criteria, A1).
Exclusion
- Diagnosis of small cell lung cancer.
- Stage IIIB NSCLC, based on the presence of malignant pleural or pericardial effusion.
- Pregnant or lactating women.
- Patients (male or female) with reproductive potential not implementing adequate contraceptive measures.
- Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC.
- Prior surgery for NSCLC, if less than 5 years from study.
- Prior radiotherapy for NSCLC.
- 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.
- Symptomatic peripheral neuropathy Grade ≥ 2 except if due to trauma.
- Other serious concomitant illness or medical conditions:
- 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.
- History of significant neurological or psychiatric disorders including dementia or seizures.
- Active infection requiring IV antibiotics.
- Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy.
- Superior vena cava syndrome contra-indicating hydration.
- Pre-existing pericardial effusion.
- Pre-existing symptomatic pleural effusion.
- Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
- Distant metastasis.
- Concurrent treatment with any other experimental anti-cancer drugs.
- Concomitant or within 4-week period administration of any other experimental drug under investigation.
- Significant ophthalmologic abnormalities.
- Moderate to severe dermatitis.
- Hypersensitivity to docetaxel, cisplatin, or any of its excipients.
- Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
- Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and not likely to complete the study.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00379717
Start Date
November 1 2006
End Date
April 1 2008
Last Update
March 13 2008
Active Locations (1)
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1
UZ Brussel
Jette, Belgium, 1090