Recurrent Non-small Cell Lung CancerPhase 1CCODG-NSCLCNCT02889666
A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer
A Phase 1 study testing Cisplatin, Carboplatin and Docetaxel in people with Recurrent Non-small Cell Lung Cancer, run by Shanghai Jiao Tong University School of Medicine at 3 sites in China.
Trial summary
The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Non-small Cell Lung Cancer
- What is being tested?
- Cisplatin, Carboplatin and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2008to Dec 2027
- Phase
- Phase 1
- 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
- Age ≤ 75 years with histologically proven NSCLC
- No severe major organ dysfunction
- WHO performance status of 0 or 1
- No prior cancer chemotherapy
- A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.
Who cannot join
- Age ≥ 76
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
- Stage IV
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
China-Japan Union Hospital, Jilin University
Changchun, Jilin, 130033
Xian-Ling Cong, M.D, 86-0431-89876626, qingzhao_jilin@126.com
- Recruiting
Shanghai 10th People's Hospital
Shanghai, 200072
Da Fu, Ph.D, 86-15921527578, fu800da900@126.com
- Recruiting
Shanghai Pulmonary Hospital, Tongji University School of Medicine
Shanghai, 200433
Chun-Yan Wu, M.D, 86-65115006-3030, 51917533@qq.com
About this study
Official title: A Multi-Center and Randomized Control Trial of Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery as Treatment for Relapsed and Refractory Non-Small Cell Lung Cancer
The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.
Read the detailed description
Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.
In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.
- Conditions
- Recurrent Non-small Cell Lung Cancer
- Being tested
- Cisplatin, Carboplatin, Docetaxel, Gemcitabine/Carboplatin, Gemcitabine/Cisplatin
- Keywords
- relapsed, non-small cell lung cancer, cisplatin, carboplatin, oxaliplatin, docetaxel, gemcitabine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol
Procedure: Preoperative chemotherapy using Cisplatin (60mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
CarboplatinDrug
Also called Paraplatin
Procedure: Preoperative chemotherapy using Carboplatin (400mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
DocetaxelDrug
Also called Taxotere
Procedure: Preoperative chemotherapy using Docetaxel (120mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Gemcitabine/CarboplatinDrug
Also called Gemzar/Paraplatin
Procedure: Preoperative chemotherapy using Gemcitabine (200mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Gemcitabine/CisplatinDrug
Also called Gemzar/Platinol
Procedure: Preoperative chemotherapy using Gemcitabine (200mg) and Cisplatin (60mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Docetaxel/OxaliplatinDrug
Also called Taxotere/Eloxatin
Procedure: Preoperative chemotherapy using Docetaxel (120mg) and Oxaliplatin (200mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Docetaxel/CarboplatinDrug
Also called Taxotere/Paraplatin
Procedure: Preoperative chemotherapy using Docetaxel (120mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
PlaceboDrug
Regular placebo in replacement of agent-specific chemotherapy was supplied to these patients.
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin | Experimental | Carboplatin-based chemotherapy (Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Carboplatin was done for 3 cycles with 30 days after last surgery. Receives: Drug: Carboplatin |
| Docetaxel | Experimental | Docetaxel-based chemotherapy (Docetaxel 120mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Docetaxel was done for 3 cycles with 30 days after last surgery. Receives: Drug: Docetaxel |
| Gemcitabine/Cisplatin | Experimental | Gemcitabine/Cisplatin-based combinational chemotherapy (Gemcitabine 200mg + Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery. Receives: Drug: Gemcitabine/Cisplatin |
| Cisplatin | Experimental | Cisplatin-based chemotherapy (Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Cisplatin was done for 3 cycles with 30 days after last surgery. Receives: Drug: Cisplatin |
| Docetaxel/Oxaliplatin | Experimental | Docetaxel/Oxaliplatin-based chemotherapy (Docetaxel 120mg + Oxaliplatin 200mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery. Receives: Drug: Docetaxel/Oxaliplatin |
| Docetaxel/Carboplatin | Experimental | Docetaxel/Carboplatin-based chemotherapy (Docetaxel 120mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery. Receives: Drug: Docetaxel/Carboplatin |
| Gemcitabine/Carboplatin | Experimental | Gemcitabine/Carboplatin-based chemotherapy (Gemcitabine 200mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery. Receives: Drug: Gemcitabine/Carboplatin |
| Placebo | Placebo comparator | No Adjuvant chemotherapy using CCODG was done for patients who had previous surgery to remove the primary non-small cell lung carcinoma but subject to tumor relapse. Instead, placebo was supplied to these patients as a comparator Arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years disease-free survival
The disease-associated survival status during the 5 years post treatment will be measured. Note the information in the Outcome Measure is only study hypothesis.
Measured: 5 years
Secondary outcomes (2)
5 years overall survival
The overall survival status during the 5 years post treatment will be measured. Information in the Outcome Measure is only study hypothesis.
Measured: 5 years
5 years metastasis-free survival
The metastasis-associated survival status during the 5 years post treatment will be measured. Information in the Outcome Measure is only study hypothesis.
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 posted5 Sep 2016 (estimated)
- Study startJan 2008
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Jilin University, Jiangxi Provincial Cancer Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Principal investigator, Yu Sun, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yu Sun, Ph.D, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889666
- Sponsor's protocol ID
- LCA-81472709
- Acronym
- CCODG-NSCLC
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2016
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Yes, there is plan to make individual participant data (IPD) available. According to the medical administration committee of our hospitals, these data will be made generally public upon the completion of the primary studies (anticipated to be July, 2017).
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center and Randomized Control Trial of Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery as Treatment for Relapsed and Refractory Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02889666
- Acronym / sponsor ID
- CCODG-NSCLC / LCA-81472709
- Conditions
- Recurrent Non-small Cell Lung Cancer
- Keywords
- relapsed, non-small cell lung cancer, cisplatin, carboplatin, oxaliplatin, docetaxel, gemcitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Jilin University, Jiangxi Provincial Cancer Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- Jan 2008
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Sep 2016 (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 if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.
Detailed description
Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.
In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Carboplatin | Experimental | Drug: CarboplatinCarboplatin-based chemotherapy (Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Carboplatin was done for 3 cycles with 30 days after last surgery. |
| Docetaxel | Experimental | Drug: DocetaxelDocetaxel-based chemotherapy (Docetaxel 120mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Docetaxel was done for 3 cycles with 30 days after last surgery. |
| Gemcitabine/Cisplatin | Experimental | Drug: Gemcitabine/CisplatinGemcitabine/Cisplatin-based combinational chemotherapy (Gemcitabine 200mg + Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery. |
| Cisplatin | Experimental | Drug: CisplatinCisplatin-based chemotherapy (Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Cisplatin was done for 3 cycles with 30 days after last surgery. |
| Docetaxel/Oxaliplatin | Experimental | Drug: Docetaxel/OxaliplatinDocetaxel/Oxaliplatin-based chemotherapy (Docetaxel 120mg + Oxaliplatin 200mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery. |
| Docetaxel/Carboplatin | Experimental | Drug: Docetaxel/CarboplatinDocetaxel/Carboplatin-based chemotherapy (Docetaxel 120mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery. |
| Gemcitabine/Carboplatin | Experimental | Drug: Gemcitabine/CarboplatinGemcitabine/Carboplatin-based chemotherapy (Gemcitabine 200mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery. |
| Placebo | Placebo comparator | Drug: PlaceboNo Adjuvant chemotherapy using CCODG was done for patients who had previous surgery to remove the primary non-small cell lung carcinoma but subject to tumor relapse. Instead, placebo was supplied to these patients as a comparator Arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≤ 75 years with histologically proven NSCLC
- No severe major organ dysfunction
- WHO performance status of 0 or 1
- No prior cancer chemotherapy
- A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.
Key exclusion criteria (5 listed)
- Age ≥ 76
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
- Stage IV
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 |
|---|---|---|
| CisplatinAlso: PlatinolProcedure: Preoperative chemotherapy using Cisplatin (60mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery. | Drug | Cisplatin |
| CarboplatinAlso: ParaplatinProcedure: Preoperative chemotherapy using Carboplatin (400mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery. | Drug | Carboplatin |
| DocetaxelAlso: TaxotereProcedure: Preoperative chemotherapy using Docetaxel (120mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery. | Drug | Docetaxel |
| Gemcitabine/CarboplatinAlso: Gemzar/ParaplatinProcedure: Preoperative chemotherapy using Gemcitabine (200mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery. | Drug | Gemcitabine/Carboplatin |
| Gemcitabine/CisplatinAlso: Gemzar/PlatinolProcedure: Preoperative chemotherapy using Gemcitabine (200mg) and Cisplatin (60mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery. | Drug | Gemcitabine/Cisplatin |
| Docetaxel/OxaliplatinAlso: Taxotere/EloxatinProcedure: Preoperative chemotherapy using Docetaxel (120mg) and Oxaliplatin (200mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery. | Drug | Docetaxel/Oxaliplatin |
| Docetaxel/CarboplatinAlso: Taxotere/ParaplatinProcedure: Preoperative chemotherapy using Docetaxel (120mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery. | Drug | Docetaxel/Carboplatin |
| PlaceboRegular placebo in replacement of agent-specific chemotherapy was supplied to these patients. | Drug | Placebo |
Primary outcome
5 years disease-free survival
Time frame: 5 years
The disease-associated survival status during the 5 years post treatment will be measured. Note the information in the Outcome Measure is only study hypothesis.
2 secondary outcomes
5 years overall survival
Time frame: 5 years
5 years metastasis-free survival
Time frame: 5 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 17 Apr 2024.
- Individual participant dataSharing planned: Yes. Yes, there is plan to make individual participant data (IPD) available. According to the medical administration committee of our hospitals, these data will be made generally public upon the completion of the primary studies (anticipated to be July, 2017).
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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.
Yu Sun, Ph.D principal investigator
Shanghai Jiao Tong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cisplatin, Carboplatin and Docetaxel in people with Recurrent Non-small Cell Lung Cancer, run by Shanghai Jiao Tong University School of Medicine at 3 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 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: looking for participants now, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yu Sun, Ph.D (86-21-54923302, sunyu@sibs.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 years disease-free survival (time frame: 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 17 Apr 2024.