Carcinoma, Non-Small-Cell LungIHRCNCT03606239
NSCLC Isotoxic Hypofractionated Chemoradiotherapy
A study testing isotoxic hypofractionated group in people with Carcinoma, Non-Small-Cell Lung, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- isotoxic hypofractionated group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Xiao-Ying Xue, Professor, +86-158-0321-0636, xxy0636@163.com
Lin, Professor
About this study
Official title: A Phase II Open-Label Multi-center Trial of Isotoxic Hypofractionated Chemoradiotherapy for NSCLC
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.
Read the 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- isotoxic hypofractionated group
- Keywords
- isotoxic, hypofractionated radiotherapy, Non-Small-Cell Lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotoxic hypofractionated groupRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| isotoxic hypofractionated group | Experimental | 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. Receives: Radiation: isotoxic hypofractionated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (4)
time to disease progression (TTP)
Record the time from the start of enrollment to the objective progression of the tumor
Measured: 5 years
progression-free survival(PFS)
Record the time from the start of enrollment to the progression of disease or death
Measured: 5 years
overall survival (OS)
Record the time from the start of enrollment to progression or primary tumors
Measured: 5 years
local control（LC）
record the proportion of no increase in primary tumor
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Feb 2019
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Xiaoying, The Second Hospital of Hebei Medical University
- Investigators
- Xiao-Ying Xue, Professor, Study chair, The Second Hospital of Hebei Medical UniversityQiang Lin, Professor, Study director, North China Petroleum Bureau General Hospital, Hebei Medical UniversityChao-Xing Liu, Professor, Study director, No.1 Hospital of Shijiazhuang City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606239
- Sponsor's protocol ID
- NSCLS isotoxic HypoRCT
- Acronym
- IHRC
- Status last verified
- May 2022
- First submitted
- 27 Jun 2018
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 33099491
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label Multi-center Trial of Isotoxic Hypofractionated Chemoradiotherapy for NSCLC
- ClinicalTrials.gov ID
- NCT03606239
- Acronym / sponsor ID
- IHRC / NSCLS isotoxic HypoRCT
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- isotoxic, hypofractionated radiotherapy, Non-Small-Cell Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| isotoxic hypofractionated group | Experimental | Radiation: isotoxic hypofractionated groupHypofractionated 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isotoxic hypofractionated groupthe 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. | Radiation | isotoxic hypofractionated group |
Primary outcome
radiation induced esophagitis and radiation induced pneumonitis
Time frame: 2 years
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
4 secondary outcomes
time to disease progression (TTP)
Time frame: 5 years
progression-free survival(PFS)
Time frame: 5 years
overall survival (OS)
Time frame: 5 years
local control（LC）
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Derived from this study: PubMed 33099491Liu 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao-Ying Xue, Professor study chair
The Second Hospital of Hebei Medical University
Qiang Lin, Professor study director
North China Petroleum Bureau General Hospital, Hebei Medical University
Chao-Xing Liu, Professor study director
No.1 Hospital of Shijiazhuang City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isotoxic hypofractionated group in people with Carcinoma, Non-Small-Cell Lung, run by The Second Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-Ying Xue, Professor (+86-158-0321-0636, xxy0636@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiation induced esophagitis and radiation induced pneumonitis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.