| - candidate number | 2525 |
| - NTR Number | NTR937 |
| - ISRCTN | ISRCTN75771514 |
| - Date ISRCTN created | 11-apr-2007 |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 20-mrt-2007 |
| - Secondary IDs | |
| - Public Title | Phase 1 study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer (LD-SCLC). |
| - Scientific Title | Phase 1 study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer (LD-SCLC). |
| - ACRONYM | N/A |
| - hypothesis | The aim of the study is to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC as a once every three weeks schedule. |
| - Healt Condition(s) or Problem(s) studied | Small cell lung cancer (SCLC) |
| - Inclusion criteria | 1. Cytologically or histologically proven SCLC; 2. Disease confined to one hemithorax without evidence of cytologically proven malignant pleural effusion; 3. No prior chemotherapy and/or radiotherapy; 4. Age 18 years or older; 5. Performance score 0 or 1; 6. Adequate organ functions (WBC > 3.0 x 10^9/L, ANC > 1.5 x 10^9/L, platelets > 100 x 10^9/L, serum creatinine < 135 mmol/L or creatinine clearance according to Cockroft-Gault formula > 60 ml/min, bilirubin < 1.25 ULN, AST/ALT < 2.5 ULN and LDH < 1.25 ULN); 7. Adequate pulmonary function (FEV1 > 30% of predicted, DLCO > 40% of predicted); 8. No prior malignancy unless 5 years in complete remission except for patients with prior breast cancer or melanoma. Patients with adequately treated basocellular carcinoma of the skin or cervical cancer are eligible; 9. Written informed consent. |
| - Exclusion criteria | 1. Other serious ilnesses; 2. Concurrent therapy with other anti-cancer drugs; 3. Pregnancy or lactation; 4. Presence of diarrhoea; 5. Presence of suspicion of bowel obstruction or chronic inflammatory bowel disease. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | no |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 6-jan-2003 |
| - planned closingdate | 1-jan-2006 |
| - Target number of participants | 9 |
| - Interventions | Patients were treated at day 1 of three-weekly cycles 1 and 4 with irinotecan and cisplatin (340 mg and 135 mg, respectively). A dose-escalation schedule of irinotecan (100/120/140/150 mg) and cisplatin (100 mg) at day 1 of cycles 2 and 3 with concurrent thoracic radiotherapy (total dose 45 Gy) was performed. At each dose level 3 patients were included. Dose-limiting toxicity (DLT) was defined as one patient in any cohort having any of the following toxicities during cycle 2 and 3 (with concurrent thoracic radiotherapy), grade III/IV non-haematological toxicity despite adequate medication (excluding grade III/IV nausea and vomiting), grade IV neutropenia lasting for more than five days or complicated by fever and/or platelets < 25 x 10^9/L, or grade IV oesophagitis or grade III oesophagitis lasting for more than two weeks. Maximum tolerated dose (MTD) was defined as two or more patients in any cohort experiencing DLT. |
| - Primary outcome | The aim of the study is to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC ias a onve every three weeks schedule. |
| - Secondary outcome | To determine the efficacy and progression-free and overall survival of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | MD, PHD MJA Jonge de |
| - CONTACT for SCIENTIFIC QUERIES | MD, PHD MJA Jonge de |
| - Sponsor/Initiator | Erasmus Medical Center - Daniel den Hoed Kliniek, afdeling Interne Oncologie |
| - Funding (Source(s) of Monetary or Material Support) | Aventis Pharma, The Netherlands |
| - Publications | Lung Cancer. 2008 Jul;61(1):123-8. Epub 2008 Jan 7. |
| - Brief summary | Chemotherapy with concurrent thoracic radiotherapy (TRT) is considered standard treatment for limited-disease small cell lung cancer (LD-SCLC). The introduction of new chemotherapeutic agents and radiotherapy regimens may improve the prognosis of patients with LD-SCLC. The camptothecin derivative irinotecan has shown good results in the treatment of patients with ED-SCLC. Cisplatin and irinotecan have synergistic anti-tumor effects. The present phase I trial was designed to determine the feasibility and tolerability of irinotecan and cisplatin in a 3-weekly schedule with concurrent once-daily TRT in LD-SCLC. |
| - Main changes (audit trail) | |
| - RECORD | 20-mrt-2007 - 29-okt-2008 |
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