NCT02709720

Study of Vinorelbine and Cisplatin as Induction Therapy With Radiotherapy in Patients With Unresectable NSCLC

Phase II Clinical Trial With Metronomic Oral Vinorelbine and Tri-weekly Cisplatin as Induction Therapy and Subsequent Concomitantly With Radiotherapy (RT) in Patients With Lung Cancer (NSCLC) Locally Advanced Unresectable

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Spanish Lung Cancer Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase II clinical trial with metronomic oral vinorelbine and tri-weekly cisplatin as induction therapy and subsequent concomitantly with radiotherapy (RT) in patients with lung cancer (NSCLC) locally advanced unresectable

Detailed description

Hypothesis: At present, administration of concomitant chemotherapy and radiation therapy is considered a treatment of choice for patients with unresectable stage III tumor selected clinically. There is at present a systemic considered standard treatment in combination with radical radiotherapy. Nor is it established a dose of standard radiation therapy, but it is known that should never be less than 60Gy57. Vinorelbine has shown a strong radio-sensitizer in-vitro37 effect. In the phase II study, The combination of oral vinorelbine with cisplatin as induction therapy and then concomitantly with radiotherapy (66Gy) has provided very encouraging efficacy results. Recently in the vortex scheme cisplatin study with oral vinorelbine concomitant maintained with radiation from the second cycle of chemotherapy was tested. It is therefore a priority in this segment pathology seeking treatment regimens that improve the effectiveness and toxicity. Metronomic chemotherapy started with the idea of administering a cytostatic divided doses, for an extended period without interruption, can provide the advantage of exposing patients to significant dose chemotherapy without worsening the toxicity profile. All this makes it an attractive treatment strategy, and can also maintain radio sensitizing effect during concomitance.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Vinorelbine	Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
DRUG	Cisplatin	Cycle 1 and 2 day 1, 80 mg/m2
DRUG	Vinorelbine	Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
DRUG	Cisplatin	Cycle 3 and 4 day 1, 80 mg/m2
RADIATION	Radiotherapy	concomitant therapy during cycles 3 and 4. Total dose: 66Gy

Timeline

• Start date: 2016-04-15
• Primary completion: 2019-04-15
• Completion: 2019-12-16
• First posted: 2016-03-16
• Last updated: 2024-01-11
• Results posted: 2024-01-11

Locations

18 sites across 1 country: Spain