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NSCLC Isotoxic Hypofractionated Chemoradiotherapy

NCT03606239 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-09

No results posted yet for this study

Summary

Radiotherapy plays an important role in non-small cell lung cancer (NSCLC), and concurrent chemoradiation is considered to be the standard treatment for locally advanced NSCLC. However, due to the patient's physical condition, comorbidities and other reasons, only about 1/3 of patients can receive concurrent chemoradiation. Radiotherapy alone or sequential chemoradiation has become the treatment protocol for most patients. Hypofractionated radiotherapy can be used in NSCLC because it can shorten the over treatment time and may potentially reduce the effect of accelerated repopulation and obtain higher biological effective dose（BED）. So far, the vast majority of radiotherapy prescriptions have given a uniform dose of 60 Gy. This unified prescription dosage approach is completely inconsistent with the concept of precision treatment. The Netherlands MAASTRO put forward the concept of in silico radiotherapy prescription, that is: the normal tissue limits are uniform, such as: V20% ≤ 30%, spinal cord V0\> 45Gy, etc., and each patient receives a different dose of radiation therapy. This radiation prescription could reach the limits of the normal tissue of every patient; if no one tissue limits were reached, the highest dose was set up to 79.2 Gy (1.8 Gy, BID). MAASTRO applied this "iso-toxic" radiotherapy prescription and used accelerated hyperfractionation technology so that each patient received the maximum individualized radiation dose as possible. We will integrate this concept with hypofractionated radiotherapy in order to further improve efficacy.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

RADIATION

isotoxic hypofractionated group

the normal tissue limits are uniform, such as: V20% ≤ 30%, spinal cord 0\> 45Gy, etc., and used hypofractionated radiotherapy technology so that each patient received the maximum individualized radiation dose as possible，and the same time use the Platinum-containing drugs: docetaxel + lobaplatin Docetaxel 60 mg/m2, d1; Lobaplatin 30 mg/m2, d1, repeated every 28 days. The first cycle of chemotherapy started on the first day of radiotherapy.Consolidate chemotherapy up to 4 cycles after radiotherapy, as above.

Sponsors & Collaborators

  • The Second Hospital of Hebei Medical University

    lead OTHER

Principal Investigators

  • Xiao-Ying Xue, Professor · The Second Hospital of Hebei Medical University

  • Qiang Lin, Professor · North China Petroleum Bureau General Hospital, Hebei Medical University

  • Chao-Xing Liu, Professor · No.1 Hospital of Shijiazhuang City

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
2019-02-01
Primary Completion
2024-02-01
Completion
2026-02-01

Countries

  • China

Study Locations

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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 NCT03606239 on ClinicalTrials.gov