Non Small Cell Lung CancerPhase 4MAGICALNCT01336192
Maintenance Gemcitabine in the Chinese Advanced Lung Cancer
A Phase 4 study testing Gemcitabine in people with Non Small Cell Lung Cancer, run by Tongji University at 1 site in China.
Trial summary
Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death. Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate measure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Apr 2013
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic confirmed diagnosis of Stage IV NSCLC according to 2009 the seventh edition of TNM staging of lung tumors.
- No disease progression after four cycles of first-line chemotherapy with gemcitabine plus cisplatin (running period) within one month before the enrollment.
- Brain metastases are permitted if treated with full course of whole brain radiotherapy without the presence of symptomatic central nervous system metastases.
- ECOG score 0-1
Who cannot join
- First-line chemotherapy other than combination treatment of gemcitabine plus cisplatin
- Other therapy including targeted therapy, immunotherapy and prior radiotherapy for the treatment of the primary tumor prior to enrollment.
- Active infection
- Inadequate liver and renal function.
- Serious concomitant systemic disorder incompatible with the study.
- Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior enrollment without recurrence)
- Presence of the pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital Medical Oncology Department
Shanghai, Shanghai Municipality, 200433
Ying Xu, MD, 86-21-65115006 ext. 1053, xuying2186@hotmail.com
Di Zheng, MD
About this study
Official title: Maintenance Gemcitabine or Best Supportive Care for the Chinese Advanced NSCLC Patients Without Progression Disease After Given Four Cycles of the Induction Chemotherapy With Gemcitabine Plus Cisplatin
Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death. Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate measure. The standard treatment for this patient population consists of third generation platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until disease progression (PD) before the administration of second-line and third-line systemic anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a selected subgroup with an improved overall prognosis.
Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC without PD after first-line chemotherapy has been confirmed to improve progression free survival (PFS) and overall survival (OS) significantly compared with placebo in two large randomized controlled studies. However, continuation gemcitabine maintenance therapy in this setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1 and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in China.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Gemcitabine, Best supportive care
- Keywords
- Advanced NSCLC, Maintenance therapy, Gemcitabine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine 1250mg/m^2 Day 1 and 8, 28 days per cycle until PD
Best supportive careDrug
Best supportive care
| Study group | Role | What they receive |
|---|---|---|
| Best supportive care | No intervention | Best supportive care |
| Maintenance gemcitabine | Experimental | Maintenance therapy of gemcitabine alone Receives: Drug: Gemcitabine; Drug: Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
From the start of maintenance therapy or Best Suppotive Care(BSC) until the date of documented progressive disease or death from any cause
Measured: 12 months
Secondary outcomes (5)
Overall Survival
From the start of maintenance therapy or BSC until the date of documented death from any cause
Measured: 18 months
Response Rate
From the start of maintenance therapy or BSC until the date of documented progressive disease
Measured: approximately 4 weeks
Time to The Progression
From the start of maintenance therapy or BSC until the date of documented progressive disease
Measured: 18 months
Health Related Quality of Life
From the start of maintenance therapy or BSC until the date of documented progressive disease or the termination of study
Measured: Approximately 4 weeks
Number of Participants with treatment-related grade III/IV adverse events
frequency and severity of adverse events and laboratory abnormalities
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Di Zheng, MD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, ChinaWen Gao, MD, Study chair, Shanghai Pulmonary Hospital, Shanghai, ChinaJianfang Xu, MD, Study director, Shanghai Pulmonary HosptialLi Wang, MD, Study director, Shanghai Pulmonary Hospital, Shanghai, ChinaMeijun Lv, MD, Study director, Shanghai Pulmonary Hospital, Shanghai, ChinaJian Ni, MD, Study director, Shanghai Pulmonary Hospital, Shanghai, ChinaJie Zhang, MD, Study director, Shanghai Pulmonary Hospital, Shanghai, ChinaBing Lu, MD, Study director, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336192
- Sponsor's protocol ID
- SHPH-11ZL113
- Acronym
- MAGICAL
- Status last verified
- Apr 2011
- First submitted
- 7 Apr 2011
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Gemcitabine or Best Supportive Care for the Chinese Advanced NSCLC Patients Without Progression Disease After Given Four Cycles of the Induction Chemotherapy With Gemcitabine Plus Cisplatin
- ClinicalTrials.gov ID
- NCT01336192
- Acronym / sponsor ID
- MAGICAL / SHPH-11ZL113
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Advanced NSCLC, Maintenance therapy, Gemcitabine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 15 Apr 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.
Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death. Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate measure. The standard treatment for this patient population consists of third generation platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until disease progression (PD) before the administration of second-line and third-line systemic anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a selected subgroup with an improved overall prognosis.
Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC without PD after first-line chemotherapy has been confirmed to improve progression free survival (PFS) and overall survival (OS) significantly compared with placebo in two large randomized controlled studies. However, continuation gemcitabine maintenance therapy in this setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1 and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best supportive care | No intervention | –Best supportive care |
| Maintenance gemcitabine | Experimental | Drug: Gemcitabine, Drug: Best supportive careMaintenance therapy of gemcitabine alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologic or cytologic confirmed diagnosis of Stage IV NSCLC according to 2009 the seventh edition of TNM staging of lung tumors.
- No disease progression after four cycles of first-line chemotherapy with gemcitabine plus cisplatin (running period) within one month before the enrollment.
- Brain metastases are permitted if treated with full course of whole brain radiotherapy without the presence of symptomatic central nervous system metastases.
- ECOG score 0-1
Key exclusion criteria (7 listed)
- First-line chemotherapy other than combination treatment of gemcitabine plus cisplatin
- Other therapy including targeted therapy, immunotherapy and prior radiotherapy for the treatment of the primary tumor prior to enrollment.
- Active infection
- Inadequate liver and renal function.
- Serious concomitant systemic disorder incompatible with the study.
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 |
|---|---|---|
| GemcitabineGemcitabine 1250mg/m^2 Day 1 and 8, 28 days per cycle until PD | Drug | Maintenance gemcitabine |
| Best supportive careBest supportive care | Drug | Maintenance gemcitabine |
Primary outcome
Progression free survival
Time frame: 12 months
From the start of maintenance therapy or Best Suppotive Care(BSC) until the date of documented progressive disease or death from any cause
5 secondary outcomes
Overall Survival
Time frame: 18 months
Response Rate
Time frame: approximately 4 weeks
Time to The Progression
Time frame: 18 months
Health Related Quality of Life
Time frame: Approximately 4 weeks
Number of Participants with treatment-related grade III/IV adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
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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.
Di Zheng, MD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Wen Gao, MD study chair
Shanghai Pulmonary Hospital, Shanghai, China
Jianfang Xu, MD study director
Shanghai Pulmonary Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gemcitabine in people with Non Small Cell Lung Cancer, run by Tongji University 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 4 inclusion and 7 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 15 Apr 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Haiping Zhang, MD (86-21-65115006 ext. 3068, zhp7341@hotmail.com), 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: 12 months). 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 15 Apr 2011.