Small Cell Lung Cancer Limited StagePhase 2CTVNCT04543890
A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC
A Phase 2 study testing Hyperfractionated radiotherapy, Hypofractionated radiotherapy and Etoposide in people with Small Cell Lung Cancer Limited Stage, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer Limited Stage
- What is being tested?
- Hyperfractionated radiotherapy, Hypofractionated radiotherapy and Etoposide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Jun 2025
- Phase
- Phase 2
- 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
- Histologically/cytologically confirmed diagnosis of SCLC.
- Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
- Patients should be between 18 and 75 years old.
- ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
- With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
- With weight loss no more than 10% within 6 months before diagnosis.
- Informed consent must be signed.
Who cannot join
- Histology confirmed the mixed NSCLC components;
- Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
- Any disease or condition contraindicated by radiotherapy or chemotherapy;
- Malignant pleural effusion and pericardial effusion;
- Pregnant and lactating women;
- The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ming Chen, MD, PhD, +86-571-88122199, chenming@zjcc.org.cn
About this study
Official title: A Multicenter, Prospective, Randomized Study Comparing Hypofractionated Radiotherapy With Hyperfractionated Radiotherapy Combined With Concurrent Chemotherapy and Omitting Clinical Target Volumes of the Primary Tumor in Limited-stage SCLC
For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority trial.
- Conditions
- Small Cell Lung Cancer Limited Stage
- Keywords
- radiotherapy, chemotherapy, radiation dose, radiotherapy target volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperfractionated radiotherapyRadiation
Thoracic radiotherapy (45 Gy/30 fractions) for the Hyperfractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).
Hypofractionated radiotherapyRadiation
Thoracic radiotherapy (45 Gy/15 fractions) for the Hypofractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).
EtoposideDrug
Also called VP-16
Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
CisplatinDrug
Also called DDP
Cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
| Study group | Role | What they receive |
|---|---|---|
| Hyperfrationated Arm | Active comparator | Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). Receives: Radiation: Hyperfractionated radiotherapy; Drug: Etoposide; Drug: Cisplatin |
| Hypofrationated Arm | Experimental | Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/15 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). Receives: Radiation: Hypofractionated radiotherapy; Drug: Etoposide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.
Measured: 2 years
Secondary outcomes (1)
Overall survival
OS, measured from the date of randomization to the date of death from any cause.
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 posted10 Sep 2020
- Study start1 May 2018
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer Limited StageStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Chinese PLA General Hospital, Guangdong Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543890
- Sponsor's protocol ID
- IRB-2018-129
- Acronym
- CTV
- Status last verified
- Sep 2020
- First submitted
- 23 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Study Comparing Hypofractionated Radiotherapy With Hyperfractionated Radiotherapy Combined With Concurrent Chemotherapy and Omitting Clinical Target Volumes of the Primary Tumor in Limited-stage SCLC
- ClinicalTrials.gov ID
- NCT04543890
- Acronym / sponsor ID
- CTV / IRB-2018-129
- Conditions
- Small Cell Lung Cancer Limited Stage
- Keywords
- radiotherapy, chemotherapy, radiation dose, radiotherapy target volume
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Chinese PLA General Hospital, Guangdong Medical College
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 10 Sep 2020 (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.
For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperfrationated Arm | Active comparator | Radiation: Hyperfractionated radiotherapy, Drug: Etoposide, Drug: CisplatinPatients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). |
| Hypofrationated Arm | Experimental | Radiation: Hypofractionated radiotherapy, Drug: Etoposide, Drug: CisplatinPatients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/15 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically/cytologically confirmed diagnosis of SCLC.
- Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
- Patients should be between 18 and 75 years old.
- ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
- With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
Key exclusion criteria (6 listed)
- Histology confirmed the mixed NSCLC components;
- Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
- Any disease or condition contraindicated by radiotherapy or chemotherapy;
- Malignant pleural effusion and pericardial effusion;
- Pregnant and lactating women;
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 |
|---|---|---|
| Hyperfractionated radiotherapyThoracic radiotherapy (45 Gy/30 fractions) for the Hyperfractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions). | Radiation | Hyperfrationated Arm |
| Hypofractionated radiotherapyThoracic radiotherapy (45 Gy/15 fractions) for the Hypofractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions). | Radiation | Hypofrationated Arm |
| EtoposideAlso: VP-16Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66. | Drug | Hyperfrationated Arm, Hypofrationated Arm |
| CisplatinAlso: DDPCisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64. | Drug | Hyperfrationated Arm, Hypofrationated Arm |
Primary outcome
Progression-free survival
Time frame: 2 years
PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.
1 secondary outcome
Overall survival
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 10 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperfractionated radiotherapy, Hypofractionated radiotherapy and Etoposide in people with Small Cell Lung Cancer Limited Stage, run by Zhejiang Cancer 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 6 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 10 Sep 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ming Chen, MD, PhD (+86-571-88122199, chenming@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years). 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 10 Sep 2020.