SCLC, Limited StagePhase 3NCT07008716
Omitting CTV for Primary Tumor in LS-SCLC
A Phase 3 study testing Radiation Therapy, Etoposide + carboplatin; Etoposide + cisplatin and Creating CTV for primary tumor in people with SCLC, Limited Stage and Radiation Exposure, run by Sun Yat-sen University at 2 sites in China.
Trial summary
This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC, Limited Stage, Radiation Exposure, Radiotherapy Side Effect
- What is being tested?
- Radiation Therapy, Etoposide + carboplatin; Etoposide + cisplatin and Creating CTV for primary tumor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jun 2025to 31 Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;
- Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;
- Have measurable lesions per RECIST 1.1 criteria;
- Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;
- Lung function test: FEV1 ≥ 1 L (Optional);
- Complete blood count: neutrophil count ≥ 1.5 x 10^9/L, hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10^9/L;
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- Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN);
- Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN;
- Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.
Who cannot join
- Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer;
- Uncontrolled heart disease or myocardial infarction within the past 6 months;
- Patients with a history of mental illness;
- Pregnant and lactating patients;
- Poorly controlled diabetes and hypertension;
- Interstitial pneumonia or active pulmonary fibrosis;
- Active infection;
- Other conditions unsuitable for enrollment (per investigator judgment).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ming Chen
- Recruiting
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang
Xiao Hu
About this study
Official title: Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial
This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive radiotherapy including CTV. The efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of LS-SCLC. The target volume of LS-SCLC may be reduced by omitting CTV without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.
- Being tested
- Radiation Therapy, Etoposide + carboplatin; Etoposide + cisplatin, Creating CTV for primary tumor, prophylactic cranial irradiation (PCI)
- Medical subject headings
- Radiation Injuries, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy
Etoposide + carboplatin; Etoposide + cisplatinDrug
Carboplatin IV (AUC=5) on day 1 combined with etoposide IV (100mg/m2) on days 1-3, or cisplatin IV (25mg/m2) on days 1-3 combined with etoposide IV (100mg/m2) on days 1-3. Treatment is repeated every 21 days for 4-6 cycles.
Creating CTV for primary tumorRadiation
A margin of 0.8 cm beyond the gross target volume of primary tumor.
prophylactic cranial irradiation (PCI)Radiation
Beginning 4-6 weeks after chemoradiotherapy completion, patients in both arms who achieve a complete or partial response without brain metastasis receive PCI at 25 Gy/10 fractions or 26 Gy/13 fractions, delivered once daily (5 days per week).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Creating CTV for primary tumor. Receives: Radiation: Radiation Therapy; Drug: Etoposide + carboplatin; Etoposide + cisplatin; Radiation: Creating CTV for primary tumor; Radiation: prophylactic cranial irradiation (PCI) |
| Experimental group | Experimental | Omitting CTV for primary tumor. Receives: Radiation: Radiation Therapy; Drug: Etoposide + carboplatin; Etoposide + cisplatin; Radiation: prophylactic cranial irradiation (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local progression free survival
Measured: From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 years
Severe toxicity free survival
Measured: From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years
Secondary outcomes (4)
Overall survival
Measured: From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years
Progression free survival
Measured: From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years
Number of participants with recurrence or metastasis as evaluated by RECIST 1.1
Measured: From the date chemotherapy commenced to the end of follow-up at 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From the date chemotherapy commenced to the end of follow-up at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start3 Jun 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Limited StageStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuohan Zheng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008716
- Sponsor's protocol ID
- B2022-792
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07008716
- Acronym / sponsor ID
- B2022-792
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 3 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 6 Jun 2025 (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.
This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive radiotherapy including CTV. The efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of LS-SCLC. The target volume of LS-SCLC may be reduced by omitting CTV without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Radiation: Radiation Therapy, Drug: Etoposide + carboplatin; Etoposide + cisplatin, Radiation: Creating CTV for primary tumor, Radiation: prophylactic cranial irradiation (PCI)Creating CTV for primary tumor. |
| Experimental group | Experimental | Radiation: Radiation Therapy, Drug: Etoposide + carboplatin; Etoposide + cisplatin, Radiation: prophylactic cranial irradiation (PCI)Omitting CTV for primary tumor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;
- Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;
- Have measurable lesions per RECIST 1.1 criteria;
- Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;
- Lung function test: FEV1 ≥ 1 L (Optional);
Key exclusion criteria (8 listed)
- Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer;
- Uncontrolled heart disease or myocardial infarction within the past 6 months;
- Patients with a history of mental illness;
- Pregnant and lactating patients;
- Poorly controlled diabetes and hypertension;
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 |
|---|---|---|
| Radiation TherapyTwice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy | Radiation | Control group, Experimental group |
| Etoposide + carboplatin; Etoposide + cisplatinCarboplatin IV (AUC=5) on day 1 combined with etoposide IV (100mg/m2) on days 1-3, or cisplatin IV (25mg/m2) on days 1-3 combined with etoposide IV (100mg/m2) on days 1-3. Treatment is repeated every 21 days for 4-6 cycles. | Drug | Control group, Experimental group |
| Creating CTV for primary tumorA margin of 0.8 cm beyond the gross target volume of primary tumor. | Radiation | Control group |
| prophylactic cranial irradiation (PCI)Beginning 4-6 weeks after chemoradiotherapy completion, patients in both arms who achieve a complete or partial response without brain metastasis receive PCI at 25 Gy/10 fractions or 26 Gy/13 fractions, delivered once daily (5 days per week). | Radiation | Control group, Experimental group |
Primary outcome
Local progression free survival
Time frame: From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 years
Severe toxicity free survival
Time frame: From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years
4 secondary outcomes
Overall survival
Time frame: From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years
Progression free survival
Time frame: From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years
Number of participants with recurrence or metastasis as evaluated by RECIST 1.1
Time frame: From the date chemotherapy commenced to the end of follow-up at 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From the date chemotherapy commenced to the end of follow-up at 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiation Therapy, Etoposide + carboplatin; Etoposide + cisplatin and Creating CTV for primary tumor in people with SCLC, Limited Stage and Radiation Exposure, run by Sun Yat-sen University at 2 sites 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Chen (86+02087343504, chenming@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local progression free survival (time frame: From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 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 6 Jun 2025.