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

Sponsor
Spanish Lung Cancer Group
Study ID
NCT02709720
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Apr 15, 2016
Status verified
Apr 2023
Primary completion
Apr 15, 2019
Completion
Dec 16, 2019

Study Design

Enrollment
68 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1 Experimental group
    2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy Induction chemotherapy: * Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles. * Metronomic oral vinorelbine: 50mg/day, 3 days of each week for 2 cycles. Concomitant chemotherapy and radiotherapy: * Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles. * Metronomic oral vinorelbine: 30mg/day, 3 days of each week for 2 cycles. 1 cycle equals 21 days Radiotherapy treatment: Patients will receive concomitant thoracic radiation therapy, using a technique three-dimensional conformal radiation therapy, using an accelerator linear that operates with energy rays ≥ 6 MV. The total target RTT dose will be 66 Gy in 33 daily fractions of 2 Gy, which will be prescribed in accordance with the document of ICRU reference 50 of ICRU.

Primary Outcome Measure

Progression-free Survival [ Time Frame: From patient inclusion up to the date of first documented progression or date of death from any cause, whichever came first, up to 24 months. ]

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