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NSCLC Isotoxic Hypofractionated Chemoradiotherapy (IHRC)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
isotoxic hypofractionated group
Sponsored by
The Second Hospital of Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring isotoxic, hypofractionated radiotherapy, Non-Small-Cell Lung

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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;
  2. Age ≥ 18 years,≤ 75 years;
  3. The expected survival period is ≥ 3 months;
  4. Karnofsky performance status (KPS) score ≥ 60;
  5. Normal blood account , liver and kidney function;
  6. Forced expiratory volume in 1 second of 0.75 L or greater.

Exclusion Criteria:

  1. Serious medical problems require hospitalization, include (but not limited to ): history of pulmonary fibrosis, previous myocardial infarction within 6 months, heart failure grade II and above, uncontrolled heart failure, uncontrolled chronic obstructive pulmonary disease (COPD), uncontrolled diabetes .et al;
  2. Esophageal invasion (cT4);
  3. Others are not suitable for receiving radiotherapy and chemotherapy.

Sites / Locations

  • The Second Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

isotoxic hypofractionated group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

time to disease progression (TTP)
Record the time from the start of enrollment to the objective progression of the tumor
progression-free survival(PFS)
Record the time from the start of enrollment to the progression of disease or death
overall survival (OS)
Record the time from the start of enrollment to progression or primary tumors
local control(LC)
record the proportion of no increase in primary tumor

Full Information

First Posted
June 27, 2018
Last Updated
May 6, 2022
Sponsor
The Second Hospital of Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03606239
Brief Title
NSCLC Isotoxic Hypofractionated Chemoradiotherapy
Acronym
IHRC
Official Title
A Phase II Open-Label Multi-center Trial of Isotoxic Hypofractionated Chemoradiotherapy for NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
Detailed Description
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 total treatment time and may potentially reduce the effect of accelerated repopulation and obtain higher BED. So far, the vast majority of radiotherapy prescriptions have given a uniform dose of radiotherapy to all patients, regardless of individual factors such as tumor size, location, and adjacent vital organs, which may cause two consequences: First, small-volume tumors may, not receive enough radiation dose, resulting in a decrease in local control rate. Second, for large volumes of tumors or tumors adjacent to vital organs, even the "so-called" standard dose (60 Gy) may cause serious damage to normal tissues. 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.From the model study to the long-term survival results, a series of encouraging results were achieved. The use of an individualized radiotherapy prescription based on iso-toxicity for the treatment of NSCLC in large-segment radiotherapy is expected to achieve: 1. For patients with small tumor volumes and no adjacent to vital organs, a higher radiation dose is given under safe conditions. 2. For patients with larger volumes of tumors or adjacent to vital organs, give safer doses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
isotoxic, hypofractionated radiotherapy, Non-Small-Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
isotoxic hypofractionated group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
isotoxic hypofractionated group
Intervention Description
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.
Primary Outcome Measure Information:
Title
radiation induced esophagitis and radiation induced pneumonitis
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
time to disease progression (TTP)
Description
Record the time from the start of enrollment to the objective progression of the tumor
Time Frame
5 years
Title
progression-free survival(PFS)
Description
Record the time from the start of enrollment to the progression of disease or death
Time Frame
5 years
Title
overall survival (OS)
Description
Record the time from the start of enrollment to progression or primary tumors
Time Frame
5 years
Title
local control(LC)
Description
record the proportion of no increase in primary tumor
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Serious medical problems require hospitalization, include (but not limited to ): history of pulmonary fibrosis, previous myocardial infarction within 6 months, heart failure grade II and above, uncontrolled heart failure, uncontrolled chronic obstructive pulmonary disease (COPD), uncontrolled diabetes .et al; Esophageal invasion (cT4); Others are not suitable for receiving radiotherapy and chemotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Ying Xue, Professor
Phone
+86-158-0321-0636
Email
xxy0636@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Ying Xue, Professor
Organizational Affiliation
The Second Hospital of Hebei Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Qiang Lin, Professor
Organizational Affiliation
North China Petroleum Bureau General Hospital, Hebei Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chao-Xing Liu, Professor
Organizational Affiliation
No.1 Hospital of Shijiazhuang City
Official's Role
Study Director
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-Ying Xue, Professor
Phone
+86-158-0321-0636
Email
xxy0636@163.com
First Name & Middle Initial & Last Name & Degree
Lin, Professor

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the publication of this study, we could share the IPD. However, this sharing is limited to academic research. Person to be contacted: Study Chair: Professor Xiao Ying Xue. Contact information: zyy_lq@petrochina.com.cn
IPD Sharing Time Frame
After the publication of this study, we could share the IPD
IPD Sharing Access Criteria
However, this sharing is limited to academic research. Person to be contacted: Study Chair: Professor Xiao Ying Xue.
Citations:
PubMed Identifier
33099491
Citation
Liu YE, Xue XY, Zhang R, Chen XJ, Ding YX, Liu CX, Qin YL, Li WQ, Ren XC, Lin Q. Study protocol: a multicentre, prospective, phase II trial of isotoxic hypofractionated concurrent chemoradiotherapy for non-small cell lung cancer. BMJ Open. 2020 Oct 23;10(10):e036295. doi: 10.1136/bmjopen-2019-036295.
Results Reference
derived

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NSCLC Isotoxic Hypofractionated Chemoradiotherapy

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