Small Cell Lung CarcinomaNCT01317953
Oral Green Tea Extract for Small Cell Lung Cancer
A study testing epigallocatechin gallate in people with Small Cell Lung Carcinoma, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
The purpose of this study is to determine whether green tea extract is safe for extensive-stage small lung cancer who achieved objective tumor response after first-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- epigallocatechin gallate
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Confirmed diagnosis of small cell lung cancer
- extensive-stage disease
- Eastern Cooperative Oncology Group performance status (PS) of 0 to 2
- age18 years old
- Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm^3, platelet count ≥ 100,000 /mm^3, hemoglobin ≥ 9 g/dl
- Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min
Show all 9Show fewer
- Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN
- Signed written informed consent prior to study entry
- According to Response Evaluation Criteria in Solid Tumors(RECIST), patients didn't progress after first-line chemotherapy
Who cannot join
- Any condition that would hamper informed consent or ability to comply with the study protocol
- Participation in another research study in the last three months
- Known malignancy at any site other than SCLC
- Recent consumption of green tea (5 or more cups per day within one week of study enrollment)
- Pregnant and lactating women
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to EGCG
Trial locations and contacts
1 site in 1 country.
China1 site
- Available
Shan Dong cancer hospital and institute
Jinan, Shandong, 250117
Xindong Sun, M.D., 0086053167626141, zhx87520052@163.com.cn
Hanxi Zhao, M.D., 0086053167626995, 171459576@qq.com
About this study
Official title: Phase ⅠStudy of Oral Green Tea Extract as Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
The purpose of this study is to determine whether green tea extract is safe for extensive-stage small lung cancer who achieved objective tumor response after first-line therapy.
Read the detailed description
Small-cell lung cancer accounts for 13 to 15% of all lung cancer and more than 60 to 70% of patients present with extensive disease (ED). Although etoposide plus cisplatin (EP) regimen has been the mainstay of ED-SCLC treatment, median overall survival is about 9 months, with 5 to 10% surviving two years and only 1% of patients achieving a long-term disease-free survival. To improve this outcome further, various attempts have been made, which included dose intensification with stem cell supports, maintenance therapy, and also searches for a better chemotherapy regimen.
Significant anticarcinogenic effects of green tea extract on various organs, such as skin, stomach, duodenum, colon, liver, pancreas, and lung in rodent models have been confirmed. Recent scientific investigations have identified the active chemical compounds in green tea designated tea polyphenols or catechins. Epigallocatechin-3-gallate (EGCG) is the major catechin in tea.An investigation about the effects of EGCG on human SCLC cells revealed that EGCG had similar anti-tumor effects on drug-sensitive (H69) and drug-resistant (H69VP) SCLC cells. Thus, the investigators conduct this phase I trial, the objectives of this trial were to study the side effects and best dose of of EGCG in treating patients with small-cell lung cancer who achieved objective tumor response after first-line therapy.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- epigallocatechin gallate
- 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.
epigallocatechin gallateDietary supplement
Also called EGCG
Starting dose green tea catechin extract "EGCG" 400 mg twice a day (BID) of EGCG (400 mg caps BID), second escalated dose 800 mg BID of EGCG (2x400 mg caps BID), third escalated dose 1200 mg BID of EGCG (3x400 mg),fourth escalated dose 1600 mg BID of EGCG (4x400 mg),and fifth escalated dose 2000 mg BID of EGCG (5x400 mg),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (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 CarcinomaStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Xi Zhao, Shandong Cancer Hospital and Institute
- Investigators
- Xindong Sun, M.D., Study director, Shan Dong Tumor Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317953
- Sponsor's protocol ID
- GTESCLC2011
- Status last verified
- Apr 2019
- First submitted
- 17 Mar 2011
- Last updated
- 5 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase ⅠStudy of Oral Green Tea Extract as Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01317953
- Acronym / sponsor ID
- GTESCLC2011
- Conditions
- Small Cell Lung Carcinoma
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- First posted
- 18 Mar 2011 (estimated)
- 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 determine whether green tea extract is safe for extensive-stage small lung cancer who achieved objective tumor response after first-line therapy.
Detailed description
Small-cell lung cancer accounts for 13 to 15% of all lung cancer and more than 60 to 70% of patients present with extensive disease (ED). Although etoposide plus cisplatin (EP) regimen has been the mainstay of ED-SCLC treatment, median overall survival is about 9 months, with 5 to 10% surviving two years and only 1% of patients achieving a long-term disease-free survival. To improve this outcome further, various attempts have been made, which included dose intensification with stem cell supports, maintenance therapy, and also searches for a better chemotherapy regimen.
Significant anticarcinogenic effects of green tea extract on various organs, such as skin, stomach, duodenum, colon, liver, pancreas, and lung in rodent models have been confirmed. Recent scientific investigations have identified the active chemical compounds in green tea designated tea polyphenols or catechins. Epigallocatechin-3-gallate (EGCG) is the major catechin in tea.An investigation about the effects of EGCG on human SCLC cells revealed that EGCG had similar anti-tumor effects on drug-sensitive (H69) and drug-resistant (H69VP) SCLC cells. Thus, the investigators conduct this phase I trial, the objectives of this trial were to study the side effects and best dose of of EGCG in treating patients with small-cell lung cancer who achieved objective tumor response after first-line therapy.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of small cell lung cancer
- extensive-stage disease
- Eastern Cooperative Oncology Group performance status (PS) of 0 to 2
- age18 years old
- Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm^3, platelet count ≥ 100,000 /mm^3, hemoglobin ≥ 9 g/dl
Key exclusion criteria (6 listed)
- Any condition that would hamper informed consent or ability to comply with the study protocol
- Participation in another research study in the last three months
- Known malignancy at any site other than SCLC
- Recent consumption of green tea (5 or more cups per day within one week of study enrollment)
- 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 |
|---|---|---|
| epigallocatechin gallateAlso: EGCGStarting dose green tea catechin extract "EGCG" 400 mg twice a day (BID) of EGCG (400 mg caps BID), second escalated dose 800 mg BID of EGCG (2x400 mg caps BID), third escalated dose 1200 mg BID of EGCG (3x400 mg),fourth escalated dose 1600 mg BID of EGCG (4x400 mg),and fifth escalated dose 2000 mg BID of EGCG (5x400 mg), | Dietary supplement | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
Related trials for Small Cell Lung Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Xindong Sun, M.D. study director
Shan Dong Tumor Hospital and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epigallocatechin gallate in people with Small Cell Lung Carcinoma, run by Shandong Cancer Hospital and Institute 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 9 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 5 Apr 2019. 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 Xindong Sun, M.D. (0086-053167626141, zhx7152028@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 Apr 2019.