Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles during RT(66 Gy/6.5 w).
Vinorelbine (NVB) + CDDP is considered a standard trt in induction or concomitantly with RT (Vokes, Fournel, Krzakowski). NVBo simplifies the administration of trt and provides the same efficacy as intravenous NVB (NVBiv). In order to assess this and to improve the tolerance, a trial was started with NVBiv and NVBo + CDDP as induction followed by a fractionated administration of NVBo + CDDP during RT.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vinorelbine cisplatin radiotherapy | Experimental | Induction period + radio chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinorelbine cisplatin radiotherapy | Drug | During the induction period, patients received chemotherapy for two 3-week cycles. Bolus intravenous vinorelbine 25 mg/m², was administered on day 1, then cisplatin 80 mg/m² was administered over 1-hour infusion. Vinorelbine 60 mg/m² was also administered on day 8. Patients with objective response (OR) or no change (NC) continued the concomitant period (CP) including two additional 3-week cycles of radio chemotherapy (vinorelvine 20 mg D1 D3 D5 Cisplatin 80 mg/m² 66 Gy). |
| Measure | Description | Time Frame |
|---|---|---|
| Disease controle | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| - duration of response (DR) | Secondary endpoints were duration of response (DR), progression-free survival (PFS), and overall survival (OS), calculated by the Kaplan-Meier method. The safety analysis reported the worst grade of the adverse events (NCI CTC v. 2.0) for the safety population. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| - progression-free survival (PFS) | up to 3 years | |
| - overall survival (OS), | up to 3 years | |
| - safety |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gérard Zalcmann, professor | Baclesse, Caen, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU CAEN | Caen | 14033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24678902 | Derived | Lerouge D, Riviere A, Dansin E, Chouaid C, Dujon C, Schott R, Lavole A, Le Pennec V, Fabre E, Crequit J, Martin F, Dehette S, Fournel P, Precheur-Agulhon B, Lartigau E, Zalcman G. A phase II study of cisplatin with intravenous and oral vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy with oral vinorelbine and cisplatin for locally advanced non-small cell lung cancer. BMC Cancer. 2014 Mar 30;14:231. doi: 10.1186/1471-2407-14-231. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| up to 3 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |