Non-small cell lung cancer, stage III MedDRA version: 9.1 Level: LLT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
Conditions
Interventions
Trade Name: Alimta (Pemetrexed)
Product Name: Pemetrexed
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Pemetrexed sodium
Other descriptive name: Alimta
Con
Sponsors
Christie Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Histologically or cytologically confirmed NSCLC (mixed small cell, non-small cell histology is not permitted) b) Inoperable Stage III disease (T4N0/1; T4N2; any TN3) confirmed by PET scanning, mediastinoscopy or thoracoscopy. c) Tumour judged inoperable by a thoracic surgeon d) Measurable or evaluable disease on CT scan e) Age >= 18, no upper age limit f) Performance status - ECOG 0 or 1 (appendix 1) g) No prior chemotherapy, radiotherapy or investigational agents h) Willing and able to give informed consent i) Patient considered able to tolerate platinum based chemotherapy and radical radiotherapy: • Creatinine clearance >= 50 ml/min. The Cockcroft and Gault formula (see appendix 5) may be used to estimate GFR, but if 4 x 109/l, absolute neutrophil count > 1.5 x 109/l, haemoglobin > 10.0 g/dl and platelet count >100 x 109/l). • Tumour that can be encompassed within a radical radiotherapy treatment volume (V20 expected to be = 1.0 L or DLCO (transfer factor) >= 50% of predicted 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
Exclusion criteria: a) Stage IIIb wet (cytologically proven malignant pleural effusion). Pleural effusion permitted if it developed after exploratory surgery or mediastinoscopy or if present only on CT scan and deemed too small to tap under ultrasound or CT guidance. b) Pericardial effusion c) Other previous or current malignant disease likely to interfere with protocol treatment or comparisons d) Abnormal LFTs with any of: alkaline phosphatase, gammaGT, transaminases or bilirubin >1.5 times upper limit of normal range e) Calcium above normal limits f) Superior vena cava symdrome, haemoptysis causing a decrease in Hb of >=1g/L g) V20 > 35% (see section 4.3.2) g)h) Medically unstable (e.g. unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia or ischaemic heart disease) h)i) Patients who are pregnant or lactating. j) Patients (of reproductive potential) who are unable to comply with effective contraception if sexually active during the study and for a period of at least 6 months after treatment. k) Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose = 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).”
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1-yr survival;Secondary Objective: • Progression free survival • 2 year survival • Late and acute Toxicity (CTCAE version 3.0-appendix 2) • Compliance to treatment • Response rate to concurrent CTRT ;Primary end point(s): 1-yr survival | — |
Countries
United Kingdom
Outcome results
None listed