Small-cell Lung CancerNCT03523234
Neoadjuvant Therapy Combined With Radical Surgery for the Treatment of Small Cell Lung Cancer (SCLC) in II and IIIA Stage
A study testing neoadjuvant chemotherapy, radical surgery for stage II and IIIA small cell lung cancer (SCLC) and prophylactic cranial irradiation in people with Small-cell Lung Cancer, run by Peng Zhang at 1 site in China.
Trial summary
The main purpose of this study is to compare the effects of neoadjuvant with radical surgery on the prognosis of patients with stage II and IIIA small cell lung cancer (SCLC). The primary endpoint of this study is to observe 5-year survival, disease-free survival (DFS), and overall survival (OS) in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- neoadjuvant chemotherapy, radical surgery for stage II and IIIA small cell lung cancer (SCLC) and prophylactic cranial irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2018to Jul 2023
- 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
- signed informed consent;
- Ability to comply with research protocols and follow-up procedures;
- The patient's age is 18 years or older;
- Histologically or cytologically confirmed as SCLC, chest-enhanced CT, liver and adrenal CT, cranial magnetic resonance, PET-CT/systemic bone imaging, etc. Definitely stage II, IIIA staged patients (according to the UICC 2009 edition staging criteria);
- Patients must have measurable lesions (according to the RECIST 1.0 standard);
- Physical status ECOG score is 0~1;
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- Life expectancy is at least 12 weeks;
- The following laboratory tests were performed within 7 days prior to the first dose to confirm that the patient's bone marrow, liver, and kidney functions met the requirements for participating in the study:
- Hemoglobin ≥ 9.0 g/dL (can be maintained or exceeded by blood transfusion);
- The absolute neutrophil count (ANC) ≥ 1.5 × 109;
- platelet count ≥100×109/mm3;
- Total bilirubin ≤ 1.5 times the upper limit of normal;
- Alanine aminotransferase and aspartate aminotransferase ≤2.5 times the normal upper limit;
- creatinine ≤ 1.5 times the upper limit of normal; and creatinine clearance ≥ 60 ml/min;
- The international normalized prothrombin time ratio (INR) is less than 1.5 in patients who have not received anticoagulant therapy, and the partial thromboplastin time (APTT) is less than 1.5 times the upper limit of normal. Patients receiving full-dose or parenteral anticoagulant therapy should be stable for at least 2 weeks before entry into clinical studies, and the results of the clotting test can be entered into clinical trials within the limits of local treatment.
- Women of childbearing age must have a pregnancy test within 7 days of starting treatment and the result is negative.
- Men and women of appropriate age must have reliable methods of contraception prior to entering the trial and during the study until 30 days after discontinuation. Reliable contraceptive methods will be determined by the principal investigator or designated person.
Who cannot join
- Conducted any systemic anti-cancer therapy for SCLC, including cytotoxic drug therapy, targeted drug therapy, and experimental therapy;
- Surgical treatment for SCLC;
- Localized radiotherapy for SCLC;
- Patients with other than SCLC cancer in the five years prior to the start of treatment in this study. Except for cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including Ta and Tis];
- Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris starting in the last 3 months, congestive heart failure (≥New York Heart Association [NYHA] Grade II), myocardial infarction (6 months prior to enrollment), severe arrhythmia requiring medication, liver, kidney, or metabolic disease;
- Has or is currently suffering from interstitial lung disease;
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- There are no fully controlled eye inflammations or eye infections, or any condition that may lead to the aforementioned eye diseases;
- Human immunodeficiency virus (HIV) infection is known;
- Allergies to any of the research drugs;
- Patients who have undergone major surgery or severe trauma within the first 2 months of the first dose;
- any malabsorption;
- pregnant or lactating women;
- Other investigators think it inappropriate to join the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Peng Zhang, doctor
About this study
The main purpose of this study is to compare the effects of neoadjuvant with radical surgery on the prognosis of patients with stage II and IIIA small cell lung cancer (SCLC). The primary endpoint of this study is to observe 5-year survival, disease-free survival (DFS), and overall survival (OS) in patients. Secondary efficacy indicators include recurrence rate, surgical complications, resection rate, quality of life (QoL), and exploration biomarker (tumor tissue).
This is a two-arm, open, multicentral clinical study designed to assess the disease-free survival (DFS) and overall survival (OS) of neoadjuvant chemotherapy plus radical surgery for stage II and IIIA small cell lung cancer (SCLC). About 300 patients will be enrolled in the study and randomly divided into two groups of 150 individuals. The neoadjuvant with radical surgery group received 2 to 4 cycles of neoadjuvant treatment with etoposide plus cisplatin/carboplatin before receiving radical surgery, followed by 2 to 4 cycles of adjuvant chemotherapy (etoposide with cisplatin/carboplatin) plus radiotherapy. Patients in the control group are planned to receive 4 to 6 courses of etoposide plus cisplatin/carboplatin for chemotherapy and radiotherapy.
Read the detailed description
Before chemotherapy is widely used in clinical work, surgery is the main method for the treatment of lung cancer. However, the prognosis of patients with small cell lung cancer (SCLC) is significantly worse than that of other histological types of lung cancer. The only two prospective studies comparing the surgery with other treatments (surgery vs. radiotherapy alone; induction chemotherapy + surgery vs. chemotherapy + radiotherapy) found that patients in surgery group had a poorer prognosis. Thus, small cell lung cancer was determined to be a non-surgically treated disease. Therefore, for patients with stage II and III A SCLC, combined radiotherapy and chemotherapy are currently recommended. The first-line chemotherapy regimens are etoposide plus cisplatin and carboplatin. Surgical treatment is currently only recommended for very early stage SCLC (T1-2N0M0) with postoperative adjuvant chemotherapy, but these patients only account for about 5% of all SCLC patients. Despite the sensitivity to chemotherapy, the long-term survival of small cell lung cancer remains unsatisfactory. For patients with limited SCLC, even if combined with local radiotherapy, there are still 1/4 to 1/3 of patients progressing due to recurrence of local lesions. So the status of surgical treatment is expected to be reassessed. In recent years, retrospective analysis results of some large databases in Europe and the United States have provided a basis for the role of surgery in the treatment of small cell lung cancer (SCLC). It is believed that surgery should be used as one of the treatment options for SCLC. Based on the results of prospective studies and retrospective studies, a well-designed, phased, prospective study is urgently needed to explore the role of surgery in the treatment of SCLC.
In neoadjuvant therapy combined with radical surgery, neoadjuvant chemotherapy is based on the combination of etoposide and cisplatin/carboplatin. Doses of the drugs are taken from the NCCN guideline for the recommended adjuvant chemotherapy for the limited-period SCLC: namely etoposide 120 mg/m2 through intravenous infusion on Day 1, 2, and 3; cisplatin 60 mg/m2 through intravenous infusion on Day 1 (or carboplatin where area under the curve AUC = 5-6); 4 weeks for a cycle, with a total of 2 cycles of neoadjuvant chemotherapy. Radical surgery is performed according to the growth of SCLC patients after neoadjuvant chemotherapy, using lobectomy or pneumonectomy combined with mediastinal lymph node dissection or sampling. 4 weeks after surgery, chemotherapy and concurrent radiotherapy will be performed. The chemotherapy regimen is the same with that of neoadjuvant chemotherapy, with 4 weeks as a cycle and a total of 2 to 4 cycles. Radiotherapy and adjuvant chemotherapy are planned to be started synchronously, the patients whose intraoperative pathology showed no lymph node metastasis (N0) will receive prophylactic brain irradiation (PCI) treatment and adjuvant chemotherapy synchronously. Within 10 days, the patients will receive a total dose of 25 Gy of PCI, once a day, 2.5 Gy of brain irradiation each time. The patients whose intraoperative pathology show that there is lymph node metastasis (N1-2) are planned to receive PCI combined with mediastinal radiation therapy: namely the patient receive a total of 45 Gy within 3 weeks at the start of adjuvant chemotherapy, twice a day, 1.5 Gy of chest irradiation each time, and the PCI treatment is the same with patients whose intraoperative pathology show there is no lymph node metastasis (N0).
- Conditions
- Small-cell Lung Cancer
- Being tested
- neoadjuvant chemotherapy, radical surgery for stage II and IIIA small cell lung cancer (SCLC), prophylactic cranial irradiation, Chemotherapy
- Keywords
- neoadjuvant therapy, surgery
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapyDrug
etoposide with cisplatin/carboplatin, undergoing in prior to the surgery
radical surgery for stage II and IIIA small cell lung cancer (SCLC)Procedure or surgery
Lobectomy/total lung resection plus mediastinal lymph node dissection.
prophylactic cranial irradiationProcedure or surgery
prophylactic cranial irradiation (PCI) undergoing with adjuvant chemotherapy simultaneously
ChemotherapyDrug
etoposide with cisplatin/carboplatin
| Study group | Role | What they receive |
|---|---|---|
| surgery group | Experimental | Not described Receives: Drug: neoadjuvant chemotherapy; Procedure: radical surgery for stage II and IIIA small cell lung cancer (SCLC); Procedure: prophylactic cranial irradiation; Drug: Chemotherapy |
| control group | Placebo comparator | Not described Receives: Procedure: prophylactic cranial irradiation; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival rate
Five-year survival rate measures survival at 5 years after treatment.
Measured: From the completion of the intervention to 5 years.
Secondary outcomes (5)
recurrence rate
Patients who develop SCLC after treatment.
Measured: In 1 year after treatment.
resection rate
Patients who are eligible to receive surgery.
Measured: At the end of Perioperative period, an average of 2 weeks.
tumor biological makers
A biomarker, or biological marker, generally refers to a measurable indicator of SCLC.
Measured: At the end of Perioperative period, an average of 2 weeks
overall survival rate
Patients with SCLC can die directly from that disease or from an unrelated cause (for example, a car accident). When the precise cause of death is not specified called the overall survival rate.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 90 months
disease-free survival rate
The period after curative treatment [disease eliminated] when no disease can be detected.
Measured: From date of randomization until the date of first documented progression, whichever came first, assessed up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study startOct 2018 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peng Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523234
- Sponsor's protocol ID
- k18-066
- Status last verified
- Sep 2018
- First submitted
- 11 Apr 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy Combined With Radical Surgery for the Treatment of Small Cell Lung Cancer (SCLC) in II and IIIA Stage
- ClinicalTrials.gov ID
- NCT03523234
- Acronym / sponsor ID
- k18-066
- Conditions
- Small-cell Lung Cancer
- Keywords
- neoadjuvant therapy, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peng ZhangUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 14 May 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.
The main purpose of this study is to compare the effects of neoadjuvant with radical surgery on the prognosis of patients with stage II and IIIA small cell lung cancer (SCLC). The primary endpoint of this study is to observe 5-year survival, disease-free survival (DFS), and overall survival (OS) in patients. Secondary efficacy indicators include recurrence rate, surgical complications, resection rate, quality of life (QoL), and exploration biomarker (tumor tissue).
This is a two-arm, open, multicentral clinical study designed to assess the disease-free survival (DFS) and overall survival (OS) of neoadjuvant chemotherapy plus radical surgery for stage II and IIIA small cell lung cancer (SCLC). About 300 patients will be enrolled in the study and randomly divided into two groups of 150 individuals. The neoadjuvant with radical surgery group received 2 to 4 cycles of neoadjuvant treatment with etoposide plus cisplatin/carboplatin before receiving radical surgery, followed by 2 to 4 cycles of adjuvant chemotherapy (etoposide with cisplatin/carboplatin) plus radiotherapy. Patients in the control group are planned to receive 4 to 6 courses of etoposide plus cisplatin/carboplatin for chemotherapy and radiotherapy.
Detailed description
Before chemotherapy is widely used in clinical work, surgery is the main method for the treatment of lung cancer. However, the prognosis of patients with small cell lung cancer (SCLC) is significantly worse than that of other histological types of lung cancer. The only two prospective studies comparing the surgery with other treatments (surgery vs. radiotherapy alone; induction chemotherapy + surgery vs. chemotherapy + radiotherapy) found that patients in surgery group had a poorer prognosis. Thus, small cell lung cancer was determined to be a non-surgically treated disease. Therefore, for patients with stage II and III A SCLC, combined radiotherapy and chemotherapy are currently recommended. The first-line chemotherapy regimens are etoposide plus cisplatin and carboplatin. Surgical treatment is currently only recommended for very early stage SCLC (T1-2N0M0) with postoperative adjuvant chemotherapy, but these patients only account for about 5% of all SCLC patients. Despite the sensitivity to chemotherapy, the long-term survival of small cell lung cancer remains unsatisfactory. For patients with limited SCLC, even if combined with local radiotherapy, there are still 1/4 to 1/3 of patients progressing due to recurrence of local lesions. So the status of surgical treatment is expected to be reassessed. In recent years, retrospective analysis results of some large databases in Europe and the United States have provided a basis for the role of surgery in the treatment of small cell lung cancer (SCLC). It is believed that surgery should be used as one of the treatment options for SCLC. Based on the results of prospective studies and retrospective studies, a well-designed, phased, prospective study is urgently needed to explore the role of surgery in the treatment of SCLC.
In neoadjuvant therapy combined with radical surgery, neoadjuvant chemotherapy is based on the combination of etoposide and cisplatin/carboplatin. Doses of the drugs are taken from the NCCN guideline for the recommended adjuvant chemotherapy for the limited-period SCLC: namely etoposide 120 mg/m2 through intravenous infusion on Day 1, 2, and 3; cisplatin 60 mg/m2 through intravenous infusion on Day 1 (or carboplatin where area under the curve AUC = 5-6); 4 weeks for a cycle, with a total of 2 cycles of neoadjuvant chemotherapy. Radical surgery is performed according to the growth of SCLC patients after neoadjuvant chemotherapy, using lobectomy or pneumonectomy combined with mediastinal lymph node dissection or sampling. 4 weeks after surgery, chemotherapy and concurrent radiotherapy will be performed. The chemotherapy regimen is the same with that of neoadjuvant chemotherapy, with 4 weeks as a cycle and a total of 2 to 4 cycles. Radiotherapy and adjuvant chemotherapy are planned to be started synchronously, the patients whose intraoperative pathology showed no lymph node metastasis (N0) will receive prophylactic brain irradiation (PCI) treatment and adjuvant chemotherapy synchronously. Within 10 days, the patients will receive a total dose of 25 Gy of PCI, once a day, 2.5 Gy of brain irradiation each time. The patients whose intraoperative pathology show that there is lymph node metastasis (N1-2) are planned to receive PCI combined with mediastinal radiation therapy: namely the patient receive a total of 45 Gy within 3 weeks at the start of adjuvant chemotherapy, twice a day, 1.5 Gy of chest irradiation each time, and the PCI treatment is the same with patients whose intraoperative pathology show there is no lymph node metastasis (N0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery group | Experimental | Drug: neoadjuvant chemotherapy, Procedure: radical surgery for stage II and IIIA small cell lung cancer (SCLC), Procedure: prophylactic cranial irradiation, Drug: Chemotherapy |
| control group | Placebo comparator | Procedure: prophylactic cranial irradiation, Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- signed informed consent;
- Ability to comply with research protocols and follow-up procedures;
- The patient's age is 18 years or older;
- Histologically or cytologically confirmed as SCLC, chest-enhanced CT, liver and adrenal CT, cranial magnetic resonance, PET-CT/systemic bone imaging, etc. Definitely stage II, IIIA staged patients (according to the UICC 2009 edition staging criteria);
- Patients must have measurable lesions (according to the RECIST 1.0 standard);
Key exclusion criteria (13 listed)
- Conducted any systemic anti-cancer therapy for SCLC, including cytotoxic drug therapy, targeted drug therapy, and experimental therapy;
- Surgical treatment for SCLC;
- Localized radiotherapy for SCLC;
- Patients with other than SCLC cancer in the five years prior to the start of treatment in this study. Except for cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including Ta and Tis];
- Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris starting in the last 3 months, congestive heart failure (≥New York Heart Association [NYHA] Grade II), myocardial infarction (6 months prior to enrollment), severe arrhythmia requiring medication, liver, kidney, or metabolic disease;
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 |
|---|---|---|
| neoadjuvant chemotherapyetoposide with cisplatin/carboplatin, undergoing in prior to the surgery | Drug | surgery group |
| radical surgery for stage II and IIIA small cell lung cancer (SCLC)Lobectomy/total lung resection plus mediastinal lymph node dissection. | Procedure or surgery | surgery group |
| prophylactic cranial irradiationprophylactic cranial irradiation (PCI) undergoing with adjuvant chemotherapy simultaneously | Procedure or surgery | control group, surgery group |
| Chemotherapyetoposide with cisplatin/carboplatin | Drug | control group, surgery group |
Primary outcome
5-year overall survival rate
Time frame: From the completion of the intervention to 5 years.
Five-year survival rate measures survival at 5 years after treatment.
5 secondary outcomes
recurrence rate
Time frame: In 1 year after treatment.
resection rate
Time frame: At the end of Perioperative period, an average of 2 weeks.
tumor biological makers
Time frame: At the end of Perioperative period, an average of 2 weeks
overall survival rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 90 months
disease-free survival rate
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 40 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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 study testing neoadjuvant chemotherapy, radical surgery for stage II and IIIA small cell lung cancer (SCLC) and prophylactic cranial irradiation in people with Small-cell Lung Cancer, run by Peng Zhang 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 17 inclusion and 13 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 5 Sep 2018. 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. Some participants in this study may receive a placebo. 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 Peng Zhang, Doctor (+86 021 651 15006, zhangpeng1121@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival rate (time frame: From the completion of the intervention to 5 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 5 Sep 2018.