Safety IssuesNCT05523908
Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer
A study testing High-dose hypofraction Arm and Low-dose hypofraction Arm (Standard BED) in people with Safety Issues and Efficacy, Self, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Concurrent chemoradiotherapy is the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Safety Issues, Efficacy, Self
- What is being tested?
- High-dose hypofraction Arm and Low-dose hypofraction Arm (Standard BED)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Aug 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old;
- ECOG 0-1;
- Small cell lung cancer;
- Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT;
- Signature of inform consent.
Who cannot join
- Younger than 18 years old or older than 75 years old;
- ECOG>1;
- Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
- Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT;
- No signature of inform consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer: A Pilot Trial
Concurrent chemoradiotherapy is the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. In 2021, a phase II trial demonstrated that 60Gy/40f twice daily was superior to the standard 45Gy/30f twice daily in light of overall survival (2y OS 74.2% vs. 39% p=0.0005), which to some extent implied that higher dose may confer better survival. Hypofractionated radiotherapy was another useful modality to increase biological effective dose with the advantage of short course and convenience. The effectiveness and safety of 60Gy/15f has been demonstrated in the treatment of locally advanced non-small cell lung cancer. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy for stage III locally advanced small cell lung cancer.
Read the detailed description
Trial Design: To enroll 36 patients diagnosed with limited stage small cell lung cancer to receive hypofraction radiotherapy (18 patients receiving high dose of 60Gy/15f and 18 patients receiving low dose of 48Gy/12f).
Primary Endpoint: Rate of radiation-induced penumonitis, esophagitis, myelosuppression (CTCAE V4.0).
Secondary Endpoint: 1-year local-regional control rate, 1-year progression-free survival rate, 1-year overall survival rate (RECIST v1.1).
Randomization: Patients would be randomly assigned to high dose group and low dose group using random number table method.
Radiotherapy CT simulation: 4-Dimensional CT (4D-CT) with intravenous contrast is recommended for simulation. Scan thickness should be less than 5 mm. Thermal mask or vacuum bag is recommended.
Target Delineation: Considering hypofraction and involved field irradiation (IFI), only Internal Tumor Volume (ITV) should be delineated without the need to delineate Clinical Tumor Volume (CTV).
Delineation of ITV: ITV should include pulmonary gross tumor and metastaticmediastinal lymph nodes. PET-CT registration with simulation CT is recommended for patients with obstructive atelectasis. For patients with suspected mediastinal lymph nodes, Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is recommended.
Production of Planning Tumor Volume (PTV): Low Dose Hypofraction Arm (48Gy/12f) PTV: PTV is produced by a margin of 5 mm added to ITV. Modification of PTV is suggested to respect anatomic boundary.
High Dose Hypofraction Arm (60Gy/15f) PTV: Planning Tumor Volume (PTV) is produced by a margin of 5 mm added to ITV. Modification of PTV is suggested to respect anatomic boundary. For patients with ITV abutting esophagus, the technique of Esophagus-Sparing Simultaneous Integrated Boost (ES-SIB) should be utilized. PTV should be modified not to cover esophagus to ensure that the maximum dose to esophagus should be ≤ 45Gy.
The dose to PTV in adjacent to esophagus could be compromised (D99% of PTV should be ≥ 51Gy).
Dosimetric Limitation: 95% prescription dose should cover 100% PTV and 95% PTV should receive 100% prescription dose. Total Lung: V20<25%, Dmean<13Gy, V5<50%. Spinal Cord: Dmax<40Gy. Heart: V30<40%, Dmean<25Gy.
Treatment Implementation: Radiotherapy is implemented every day. Cone-beam CT should utilized every day to minimize set-up error.
Concurrent Chemotherapy: Chemotherapy etoposide with cisplatin for 4-6 cycles was recommended.
Prophylactic Cranial Irradiation (PCI): Patients evaluated as partial response or complete response after chemoradiotherapy were recommended to receive hippocampus-sparing prophylactic cranial irradiation.
Follow-up: Patients should be follow-up every three months right after the completion of prophylactic cranial irradiation to 3 years after that. Then follow-up every half year is allowed to 5 years. After 5 years, follow-up every year is appropriate. In follow-up, chest CT and abdominal ultrasonography should be implemented. Cranial MRI should be performed every half year. Bone scan should be undertaken every year for all patients.
- Conditions
- Safety Issues, Efficacy, Self
- Being tested
- High-dose hypofraction Arm, Low-dose hypofraction Arm (Standard BED)
- Keywords
- Hypofraction RT, Limited-Stage SCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose hypofraction ArmRadiation
Patients in this arm would receive high-dose fractionated radiotherapy with 60Gy/15f
Low-dose hypofraction Arm (Standard BED)Radiation
Patients in this arm would receive low-dose fractionated radiotherapy with 48Gy/12f
| Study group | Role | What they receive |
|---|---|---|
| High-dose hypofraction Arm | Experimental | Patients in this arm (High-dose hypofraction Arm) would receive high-dose fractionated radiotherapy with 60Gy/15f. Receives: Radiation: High-dose hypofraction Arm |
| Low-dose hypofraction Arm (Standard BED) | Experimental | Patients in this arm (Low-dose hypofraction Arm) would receive high-dose fractionated radiotherapy with 48Gy/12f. Receives: Radiation: Low-dose hypofraction Arm (Standard BED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of radiation-induced pneumonitis (CTCAE V4.0)
Rate of radiation-induced pneumonitis (CTCAE V4.0)
Measured: 1 to 2 years
Rate of radiation-induced esophagitis (CTCAE V4.0)
Rate of radiation-induced esophagitis (CTCAE V4.0)
Measured: 1 to 2 years
Rate of myelosuppression (CTCAE V4.0)
Rate of myelosuppression (CTCAE V4.0)
Measured: 1 to 2 years
Secondary outcomes (1)
2 year locoregional control rate (RECIST 1.1)
2 year locoregional control rate (RECIST 1.1)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Feb 2022
- Primary completion31 Aug 2023
- Study completion1 Aug 2024
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 Safety IssuesStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two parallel group with each of 18 patients. One group would receive high-dose hypofraction radiotherapy of 60Gy/15f and the other group would receive low-dose hypofraction radiotherapy of 48Gy/12f.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dong Qian, Anhui Provincial Hospital
- Investigators
- Dong P Qian, M.D., Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523908
- Sponsor's protocol ID
- 2022ky454
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li XY, Yan B, Zhang JQ, Li Y, Xia DQ, Xie W, He Y, Wang JG, Ma J, Cao LJ, Qian D. Short-course hypofractionated radiotherapy of 4 Gy per fraction for limited-stage small cell lung cancer: a randomized pilot trial. Transl Lung Cancer Res. 2025 Aug 31;14(8):2996-3008. doi: 10.21037/tlcr-2025-281. Epub 2025 Aug 26.
PubMed 40948832
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer: A Pilot Trial
- ClinicalTrials.gov ID
- NCT05523908
- Acronym / sponsor ID
- 2022ky454
- Conditions
- Safety Issues, Efficacy, Self
- Keywords
- Hypofraction RT, Limited-Stage SCLC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 1 Sep 2022 (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.
Concurrent chemoradiotherapy is the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. In 2021, a phase II trial demonstrated that 60Gy/40f twice daily was superior to the standard 45Gy/30f twice daily in light of overall survival (2y OS 74.2% vs. 39% p=0.0005), which to some extent implied that higher dose may confer better survival. Hypofractionated radiotherapy was another useful modality to increase biological effective dose with the advantage of short course and convenience. The effectiveness and safety of 60Gy/15f has been demonstrated in the treatment of locally advanced non-small cell lung cancer. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy for stage III locally advanced small cell lung cancer.
Detailed description
Trial Design: To enroll 36 patients diagnosed with limited stage small cell lung cancer to receive hypofraction radiotherapy (18 patients receiving high dose of 60Gy/15f and 18 patients receiving low dose of 48Gy/12f).
Primary Endpoint: Rate of radiation-induced penumonitis, esophagitis, myelosuppression (CTCAE V4.0).
Secondary Endpoint: 1-year local-regional control rate, 1-year progression-free survival rate, 1-year overall survival rate (RECIST v1.1).
Randomization: Patients would be randomly assigned to high dose group and low dose group using random number table method.
Radiotherapy CT simulation: 4-Dimensional CT (4D-CT) with intravenous contrast is recommended for simulation. Scan thickness should be less than 5 mm. Thermal mask or vacuum bag is recommended.
Target Delineation: Considering hypofraction and involved field irradiation (IFI), only Internal Tumor Volume (ITV) should be delineated without the need to delineate Clinical Tumor Volume (CTV).
Delineation of ITV: ITV should include pulmonary gross tumor and metastaticmediastinal lymph nodes. PET-CT registration with simulation CT is recommended for patients with obstructive atelectasis. For patients with suspected mediastinal lymph nodes, Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is recommended.
Production of Planning Tumor Volume (PTV): Low Dose Hypofraction Arm (48Gy/12f) PTV: PTV is produced by a margin of 5 mm added to ITV. Modification of PTV is suggested to respect anatomic boundary.
High Dose Hypofraction Arm (60Gy/15f) PTV: Planning Tumor Volume (PTV) is produced by a margin of 5 mm added to ITV. Modification of PTV is suggested to respect anatomic boundary. For patients with ITV abutting esophagus, the technique of Esophagus-Sparing Simultaneous Integrated Boost (ES-SIB) should be utilized. PTV should be modified not to cover esophagus to ensure that the maximum dose to esophagus should be ≤ 45Gy.
The dose to PTV in adjacent to esophagus could be compromised (D99% of PTV should be ≥ 51Gy).
Dosimetric Limitation: 95% prescription dose should cover 100% PTV and 95% PTV should receive 100% prescription dose. Total Lung: V20<25%, Dmean<13Gy, V5<50%. Spinal Cord: Dmax<40Gy. Heart: V30<40%, Dmean<25Gy.
Treatment Implementation: Radiotherapy is implemented every day. Cone-beam CT should utilized every day to minimize set-up error.
Concurrent Chemotherapy: Chemotherapy etoposide with cisplatin for 4-6 cycles was recommended.
Prophylactic Cranial Irradiation (PCI): Patients evaluated as partial response or complete response after chemoradiotherapy were recommended to receive hippocampus-sparing prophylactic cranial irradiation.
Follow-up: Patients should be follow-up every three months right after the completion of prophylactic cranial irradiation to 3 years after that. Then follow-up every half year is allowed to 5 years. After 5 years, follow-up every year is appropriate. In follow-up, chest CT and abdominal ultrasonography should be implemented. Cranial MRI should be performed every half year. Bone scan should be undertaken every year for all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two parallel group with each of 18 patients. One group would receive high-dose hypofraction radiotherapy of 60Gy/15f and the other group would receive low-dose hypofraction radiotherapy of 48Gy/12f.
| Arm | Type | Receives |
|---|---|---|
| High-dose hypofraction Arm | Experimental | Radiation: High-dose hypofraction ArmPatients in this arm (High-dose hypofraction Arm) would receive high-dose fractionated radiotherapy with 60Gy/15f. |
| Low-dose hypofraction Arm (Standard BED) | Experimental | Radiation: Low-dose hypofraction Arm (Standard BED)Patients in this arm (Low-dose hypofraction Arm) would receive high-dose fractionated radiotherapy with 48Gy/12f. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-75 years old;
- ECOG 0-1;
- Small cell lung cancer;
- Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT;
- Signature of inform consent.
Key exclusion criteria (5 listed)
- Younger than 18 years old or older than 75 years old;
- ECOG>1;
- Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
- Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT;
- No signature of inform consent.
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 |
|---|---|---|
| High-dose hypofraction ArmPatients in this arm would receive high-dose fractionated radiotherapy with 60Gy/15f | Radiation | High-dose hypofraction Arm |
| Low-dose hypofraction Arm (Standard BED)Patients in this arm would receive low-dose fractionated radiotherapy with 48Gy/12f | Radiation | Low-dose hypofraction Arm (Standard BED) |
Primary outcome
Rate of radiation-induced pneumonitis (CTCAE V4.0)
Time frame: 1 to 2 years
Rate of radiation-induced pneumonitis (CTCAE V4.0)
Rate of radiation-induced esophagitis (CTCAE V4.0)
Time frame: 1 to 2 years
Rate of radiation-induced esophagitis (CTCAE V4.0)
Rate of myelosuppression (CTCAE V4.0)
Time frame: 1 to 2 years
Rate of myelosuppression (CTCAE V4.0)
1 secondary outcome
2 year locoregional control rate (RECIST 1.1)
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 40948832Li XY, Yan B, Zhang JQ, Li Y, Xia DQ, Xie W, He Y, Wang JG, Ma J, Cao LJ, Qian D. Short-course hypofractionated radiotherapy of 4 Gy per fraction for limited-stage small cell lung cancer: a randomized pilot trial. Transl Lung Cancer Res. 2025 Aug 31;14(8):2996-3008. doi: 10.21037/tlcr-2025-281. Epub 2025 Aug 26.
- 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.
Dong P Qian, M.D. principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose hypofraction Arm and Low-dose hypofraction Arm (Standard BED) in people with Safety Issues and Efficacy, Self, run by Anhui Provincial 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of radiation-induced pneumonitis (CTCAE V4.0) (time frame: 1 to 2 years). The study lists 3 primary outcomes in all. 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 NCT05523908, 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 21 Aug 2024.