NSCLC Isotoxic Hypofractionated Radiotherapy

NCT03606291 | Unknown DMC

• 1 other identifier: NSCLC isotoxic HypoRT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 0\> 45Gy, etc., 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 patient survival.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

isotoxic; hypofractionation; Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• radiation induced esophagitis and radiation induced pneumonitis

  Number of participants with treatment-related severe adverse events：Grade IV radiation esophagitis, Grade III radiation esophagitis which results in interruption of radiotherapy for 7 days or more and Grade III or above radiation pneumonitis

  2 years

Secondary Outcomes (4)

• TTP

  5 years

• PFS

  5 years

• OS

  5 years

• LC

  5 years

Study Arms (1)

isotoxic hypofractionation group

EXPERIMENTAL

1\. Hypofractionated radiation: 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 ≤ 72Gy 3. Maximum limit: If the limit of any "A" is not reached, the maximum radiation dose is 72 Gy. The lowest radiation dose: 45Gy.

Radiation: isotoxic hypofractionation

Interventions

isotoxic hypofractionation RADIATION

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

isotoxic hypofractionation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• The expected survival period is ≥ 3 months;
• KPS score ≥ 60;
• Normal blood count,liver and kidney function ≤ 2.5 times the upper limit of normal;

You may not qualify if:

• Serious medical problems require hospitalization, included (but not limited to ): history of pulmonary fibrosis, previous myocardial infarction within 6 months, heart failure grade II and above, uncontrolled heart failure, uncontrolled COPD, uncontrolled diabetes Wait;
• Esophageal invasion (cT4);
• Others are not suitable for receiving radiotherapy.

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiao-Ying Xue, Professor

  The Second Hospital of Hebei Medical University

  STUDY DIRECTOR

• Qiang Lin, Professor

  North China Petroleum Bureau General Hospital, Hebei Medical University

  STUDY DIRECTOR

• Chao-Xing Liu, Professor

  No.1 Hospital of Shijiazhuang City

  STUDY DIRECTOR

Central Study Contacts

Xiao-Ying Xue, Professor

CONTACT

+86-158-0321-0636; xxy0636@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiotherapy

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 30, 2018
• Study Start: February 1, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2026
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)