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Hypofractionated Accelerated Radiotherapy With Concomitant Chemotherapy for NSCLC

NCT02367443 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2019-11-06

No results posted yet for this study

Summary

This is a phase I/II trial on concomitant RT-full dose CHT using accelerated hypofractionation schedule as currently being in routine use in Poland for sequential combination or RT alone. Objectives of the study are: to estimate rate of grade ≥ 3 CTCAE adverse effects related to treatment and to estimate tumor control, progression free-survival, and overall survival in patients treated with this regimen. Stage III NSCLC patients are treated according to the following schedule: RT: 58.8 Gy in 21 fractions (2.8 Gy/fraction, 5 times a week, 6 times in the third week; CHT concomitant with RT (2 cycle of Cisplatinum and Vinorelbine, every 21 days). Feasibility of the studied approach is evaluated by scoring the toxicity during RT-CHT and therafter, as well as percentage of treatment completion; efficacity is evaluated by estimation of local control and survival. If toxicity and efficacity are similar or better than those observed in modern series of conventionally fractionated RT-CHT, the studied regimen will become a routine treatment schedule in our institution in order to spare RT resources. In the future, a randomized comparison of the studied schedule with conventionally fractionated RT-CHT for locally advanced NSCLC is also planned.

Conditions

Interventions

RADIATION

Radiation

Radiation: Accelerated Hypofractionated radiotherapy with full dose Chemotherapy

Sponsors & Collaborators

  • Independent Public Care Health Facility of the Ministry of the Interior and Warmian & Mazurian Oncology Centre

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2019-10-31
Completion
2020-01-01

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367443 on ClinicalTrials.gov