NSCLC, inoperable stage III
Conditions
Interventions
All patients will receive one cycle of pemetrexed 500 mg/m2 and cisplatin 80 mg/m2 (standard systemic dose) before concurrent radiotherapy starts. One cycle is 3 weeks. Patients should have recovered
Sponsors
ErasmusMC Rotterdam, afdeling Longziekten
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis (bronchial brushings and washings or CT-guided fine needle aspiration) of NSCLC, stage III which is not amenable to surgical resection 2. Unidimensional or bidimensional disease on CT scan of the chest. Measurable tumour and/or nodal mass not exceeding 6 cm in largest diameter. 3. Received no prior chemotherapy or radiation therapy. 4. Performance Status 0-1 on the WHO Scale (Appendix A) 5. Estimated life expectancy of at least 24 weeks. 6. Patient compliance and geographic proximity that allow adequate follow-up. 7. Adequate bone marrow reserve: White blood count (WBC) ³ 3.0 ´ 109/L, platelets ³ 100 ´ 109/L, haemoglobin ³ 6 mmol/L (³ 9.6g/dl ) 8. Adequate respiratory function: Forced expiratory volume in 1 second (FEV1) ³1.0 L/s (>30%) and transfer factor for carbon monoxide (DLCO) ³ 40% of predicted. 9. Age ³18 years. 10. Written informed consent from patients. 11. Effective use of contraception for both males and females if appropriate during and for 3 months following end of study.
Exclusion criteria
Exclusion criteria: 1. Evidence of active infection at the discretion of the investigator. 2. Inadequate liver function: bilirubin >1.5 times normal, ALT or AST >3 times normal. 3. Inadequate renal function: calculated creatinine clearance using Cockcroft-Gault formula of < 60 ml/min. 4. Hypercalcemia 5. Evidence of extrathoracic metastases/ Stage IIIB with supraclavicular lymph nodes. 6. Uncontrolled superior vena cava syndrome, haemoptysis causing a decrease of blood hemoglobin of ³1 g/L (³0.062 mmol/L) in 24 hours, or other situations which make complete staging or treatment planning impossible. 7. Pleural effusion with positive cytology. 8. Pregnancy. 9. Breast feeding. 10. Serious concomitant systemic disorder incompatible with the study. 11. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated non-melanomatous skin cancer ), unless off treatment and in remission for greater than 5 years. 12. Use of any investigational agent in the month before enrollment into the study. 13. Any co-morbid pulmonary disease that may put the patient at risk of toxicity: specifically interstitial lung disease (fibrosis) and serious chronic pulmonary disease. 14. Patients who are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long acting agents such as piroxicam). Patients that cannot be treated with folic acid and vitamin B12 and dexamethasone. 15. Presence of clinically detectable (by physical examination) third-space fluid collections, for example ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to the study entry. 16. Use of Growth factors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine the maximum tolerated dose of pemetrexed, cisplatin and radical involved-field radiotherapy in the treatment of patients with unresectable Stage III NSCLC. Two MTD’s will be determined: 1. MTD of pemetrexed and cisplatin in combination with conventional radiotherapy . 2. MTD of pemetrexed and cisplatin with hypofractionated radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are the following: 1. the incidence and nature of acute toxicities. 2. the incidence and nature of delayed toxicity at 3-6-12 months after final radiotherapy treatment 3. objective tumour response 4. progression free survival 5. overall survival | — |
Contacts
Public ContactV.F.M. Surmont
Erasmus Medical Center - Daniel den Hoed P.O. Box 5201
Outcome results
None listed