Lung CancerNCT03833193
Moderate Hypofractionated Radiotherapy for Lung Cancer
A study testing Hypofractionated radiotherapy in people with Lung Cancer, run by North China Petroleum Bureau General Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia of patients with advanced lung cancer treated with moderate hypofractionated (3Gy/f) radiotherapy, and their predictors. Efficacies are also evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Hypofractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2016to 1 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with previously untreated advanced lung cancer were recruited, who were confirmed pathologically or cytologically.
- The Karnofsky performance status (KPS) score ≥60.
- The expected survival time was≥3 months.
- The laboratory examination results showed a neutrophil count ≥2.0 × 109, a hemoglobin level ≥100 g/L, a platelet count ≥100 × 109, and enough liver and kidney functions.
- The patients did not show abnormal electrocardiogram (ECG) results.
- They did not have other combined diseases that required hospitalization.
- Informed consent required before enrollment.
Who cannot join
- Patients who were pregnant or breastfeeding.
- Patients who had another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years), could not receive concurrent chemotherapy due to medical reasons.
- Superior vena cava syndrome.
- Syndrome and severe lung diseases that affected lung function were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
North China Petroleum Bureau General Hospital
Cangzhou, Hebei, 062552
QIANG LIN, Dr, +86-317-272-1951, billhappy001@163.com
About this study
Official title: Moderate Hypofractionated(3Gy/f) Radiotherapy for Advanced Lung Cancer: a Retrospective Study.
The purpose of this study is to evaluate the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia of patients with advanced lung cancer treated with moderate hypofractionated (3Gy/f) radiotherapy, and their predictors. Efficacies are also evaluated.
Read the detailed description
Radiotherapy plays an irreplaceable role in lung cancer. However, due to the long duration of conventional fractionation irradiation, tumor cells will accelerate repopulation after 3 to 4 weeks during radiotherapy, resulting in decreased efficacy. Hypofractionated radiation is increasingly used in radiotherapy of lung cancer. It can shorten the overall treatment time, and can potentially reduce the effect of tumor accelerated repopulation. Compared with conventional radiotherapy, hypofractionated radiotherapy can theoretically obtain a higher biological effective dose (BED). The application of Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SABR) in advanced or central lung cancer is restricted when the tumors are adjacent to important organs. Moderate hypofractionated radiotherapy can not only shorten the overall total treatment time, but also reduce the severe toxicities. It is widely used in lung cancer nowadays. However, most data of the tolerated doses for normal tissue and organs comes from conventional radiotherapy. Whether or not it is suitable for hypofractionated radiotherapy has not been determined. In our study, the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia, as well as their predictors, were obtained by retrospective analysis of patients received moderate hypofractionated radiotherapy of 3Gy/f. At the same time, the efficacies of this scheme are also evaluated.
- Conditions
- Lung Cancer
- Being tested
- Hypofractionated radiotherapy
- Keywords
- Hypofractionated radiotherapy;, Radiation-reduced esophagitis;, Radiation-reduced pneumonitis;Predictor
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapyRadiation
Radiation: Hypofractionated radiotherapy at 3Gy/f
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiotherapy | Experimental | The patients received daily accelerated radiotherapy with a total dose of 60Gy, delivered at 3Gy per fraction, five fractions per week, completed within 4 weeks. Receives: Radiation: Hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade III and above radiation-reduced esophagitis
Incidence of grade III and above radiation-reduced esophagitis
Measured: three years
Incidence of grade III and above radiation-reduced pneumonitis
Incidence of grade III and above radiation-reduced pneumonitis
Measured: three years
Secondary outcomes (5)
Objective Response Rate
ORR
Measured: three years
Local Control Rate
LCR
Measured: three years
Progression Free Survival
PFS
Measured: three years
Median Survival Time
MST
Measured: three years
Overall Survival
OS
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Nov 2016
- Primary completion1 May 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North China Petroleum Bureau General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- QIANG LIN, Dr, Study director, North China Petroleum Bureau General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833193
- Sponsor's protocol ID
- NorthChinaPBGHA
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2019
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Hypofractionated(3Gy/f) Radiotherapy for Advanced Lung Cancer: a Retrospective Study.
- ClinicalTrials.gov ID
- NCT03833193
- Acronym / sponsor ID
- NorthChinaPBGHA
- Conditions
- Lung Cancer
- Keywords
- Hypofractionated radiotherapy;, Radiation-reduced esophagitis;, Radiation-reduced pneumonitis;Predictor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- North China Petroleum Bureau General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 6 Feb 2019 (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.
The purpose of this study is to evaluate the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia of patients with advanced lung cancer treated with moderate hypofractionated (3Gy/f) radiotherapy, and their predictors. Efficacies are also evaluated.
Detailed description
Radiotherapy plays an irreplaceable role in lung cancer. However, due to the long duration of conventional fractionation irradiation, tumor cells will accelerate repopulation after 3 to 4 weeks during radiotherapy, resulting in decreased efficacy. Hypofractionated radiation is increasingly used in radiotherapy of lung cancer. It can shorten the overall treatment time, and can potentially reduce the effect of tumor accelerated repopulation. Compared with conventional radiotherapy, hypofractionated radiotherapy can theoretically obtain a higher biological effective dose (BED). The application of Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SABR) in advanced or central lung cancer is restricted when the tumors are adjacent to important organs. Moderate hypofractionated radiotherapy can not only shorten the overall total treatment time, but also reduce the severe toxicities. It is widely used in lung cancer nowadays. However, most data of the tolerated doses for normal tissue and organs comes from conventional radiotherapy. Whether or not it is suitable for hypofractionated radiotherapy has not been determined. In our study, the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia, as well as their predictors, were obtained by retrospective analysis of patients received moderate hypofractionated radiotherapy of 3Gy/f. At the same time, the efficacies of this scheme are also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiotherapy | Experimental | Radiation: Hypofractionated radiotherapyThe patients received daily accelerated radiotherapy with a total dose of 60Gy, delivered at 3Gy per fraction, five fractions per week, completed within 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with previously untreated advanced lung cancer were recruited, who were confirmed pathologically or cytologically.
- The Karnofsky performance status (KPS) score ≥60.
- The expected survival time was≥3 months.
- The laboratory examination results showed a neutrophil count ≥2.0 × 109, a hemoglobin level ≥100 g/L, a platelet count ≥100 × 109, and enough liver and kidney functions.
- The patients did not show abnormal electrocardiogram (ECG) results.
Key exclusion criteria (4 listed)
- Patients who were pregnant or breastfeeding.
- Patients who had another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years), could not receive concurrent chemotherapy due to medical reasons.
- Superior vena cava syndrome.
- Syndrome and severe lung diseases that affected lung function were excluded.
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 |
|---|---|---|
| Hypofractionated radiotherapyRadiation: Hypofractionated radiotherapy at 3Gy/f | Radiation | Hypofractionated radiotherapy |
Primary outcome
Incidence of grade III and above radiation-reduced esophagitis
Time frame: three years
Incidence of grade III and above radiation-reduced esophagitis
Incidence of grade III and above radiation-reduced pneumonitis
Time frame: three years
Incidence of grade III and above radiation-reduced pneumonitis
5 secondary outcomes
Objective Response Rate
Time frame: three years
Local Control Rate
Time frame: three years
Progression Free Survival
Time frame: three years
Median Survival Time
Time frame: three years
Overall Survival
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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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.
QIANG LIN, Dr study director
North China Petroleum Bureau General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated radiotherapy in people with Lung Cancer, run by North China Petroleum Bureau General Hospital 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 7 inclusion and 4 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 23 Mar 2023. 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 QIANG LIN, Dr (+86-177-177-37955 ext. +86-317-272195, billhappy001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade III and above radiation-reduced esophagitis (time frame: three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2023.