A Phase II Open-Label Multi-center Trial of Isotoxic Hypofractionated Chemoradiotherapy for NSCLC

Who is this study for? Patients with locally advanced NSCLC
What treatments are being studied? Isotoxic hypofractionated chemoradiotherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Pathological or cytological diagnosis of non-small cell lung cancer patients, the clinical stage using the eighth edition of American Joint Committee on Cancer(AJCC), including stage III without resectable or who when SBRT/SABR are not suitable;

• Age ≥ 18 years,≤ 75 years;

• The expected survival period is ≥ 3 months;

• Karnofsky performance status (KPS) score ≥ 60;

• Normal blood account , liver and kidney function;

• Forced expiratory volume in 1 second of 0.75 L or greater.

Locations
Other Locations
China
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Contact Information
Primary
Xiao-Ying Xue, Professor
xxy0636@163.com
+86-158-0321-0636
Time Frame
Start Date: 2019-02-01
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 30
Treatments
Experimental: isotoxic hypofractionated group
Hypofractionated radiation:~1\. Split mode: 3Gy/f. 2,Individualized prescriptions for different patients:~(1) Spinal cord: 0%\>45 Gy, and ≤2 Gy each time Lung: V20≤30%, V5≤65%, MLD≤16Gy Esophagus: highest dose ≤ 69Gy 3. Maximum limit: If the limit of any A is not reached, the maximum radiation dose is 69 Gy. The lowest radiation dose: 45Gy.~Chemotherapy:~Platinum-containing two-drug regimen: 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.~The same chemotherapy regimen is used up to 4 cycles as consolidation after the completion of radiotherapy.
Sponsors
Leads: The Second Hospital of Hebei Medical University

This content was sourced from clinicaltrials.gov