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. - TomoCT

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Informed consent (A4) 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:
iv.Serum creatinine < 1 x the upper limit of normal (UNL).
v.In case of borderline value of serum creatinine, the 24h creatinine clearance should be > 60 ml/min.
Hepatic function:
vi.Serum bilirubin < 1 x UNL
vii.ASAT and ALAT < 2.5 x UNL
viii.alkaline phosphatase < 5 x UNL
ix.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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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