Non-small Cell Lung CancerPhase 2NCT01872403
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung
A Phase 2 study testing nanoparticle albumin-bound paclitaxel/carboplatin in people with Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- nanoparticle albumin-bound paclitaxel/carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Histological or cytological diagnosis of lung squamous cell carcinoma of stage IIB and IIIA.
- 2.18 years or older 3.ECOG Performance Status no more than 2; 4.Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI; 5.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5 x 10E9/L, platelets 100 x 10E9/L; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases; 8.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).
Who cannot join
- Any systemic anticancer treatment for NSCLC
- Local radiotherapy for NSCLC.
- In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.
- Any instability in systemic disease, including: active infection, absence of control hypertension, unstable angina, begins in the last 3 months of angina pectoris, congestive heart failure
- HIV infection;
- Allergic to paclitaxel or Platinum;
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- mixed with adenocarcinoma, small cell lung cancer;
- Pregnant or lactating women;
- Other researchers believe that does not fit into the group
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120
jianxing HE, MD, +86-20-83062808, hejx@vip.163.com
xinyun yang, master, +86-20-83062808, yxy701@126.com
About this study
Official title: Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung: Parallel Control and Single Center
Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.
Read the detailed description
Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore, this program is applied to neoadjuvant therapy, may obtain better tumor pathological remission rate, improve the operation resection rate, thus improve the prognosis.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- nanoparticle albumin-bound paclitaxel/carboplatin
- Keywords
- Squamous Cell Carcinoma of the lung
- 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.
nanoparticle albumin-bound paclitaxel/carboplatinDrug
Also called paclitaxel /carboplatin
Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin vs. paclitaxel /carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung:
| Study group | Role | What they receive |
|---|---|---|
| nanoparticle albumin-bound paclitaxel | Experimental | Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung Receives: Drug: nanoparticle albumin-bound paclitaxel/carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor ORR and Number of Adverse Events
Measured: From date of randomization until the date of progression, assessed up to 2 months
Secondary outcomes (1)
PFS
Measured: From date of surgery until the date of first documented progression, assessed up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2015 (estimated)
- Study completionDec 2017 (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.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- jianxing he, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872403
- Sponsor's protocol ID
- FAH20120906
- Other IDs
- FAHGuangzhou011
- Status last verified
- Jun 2013
- First submitted
- 15 May 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung: Parallel Control and Single Center
- ClinicalTrials.gov ID
- NCT01872403
- Acronym / sponsor ID
- FAH20120906
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Squamous Cell Carcinoma of the lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jun 2013 (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.
Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.
Detailed description
Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore, this program is applied to neoadjuvant therapy, may obtain better tumor pathological remission rate, improve the operation resection rate, thus improve the prognosis.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nanoparticle albumin-bound paclitaxel | Experimental | Drug: nanoparticle albumin-bound paclitaxel/carboplatinNeoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Histological or cytological diagnosis of lung squamous cell carcinoma of stage IIB and IIIA.
- 2.18 years or older 3.ECOG Performance Status no more than 2; 4.Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI; 5.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5 x 10E9/L, platelets 100 x 10E9/L; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases; 8.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).
Key exclusion criteria (9 listed)
- Any systemic anticancer treatment for NSCLC
- Local radiotherapy for NSCLC.
- In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.
- Any instability in systemic disease, including: active infection, absence of control hypertension, unstable angina, begins in the last 3 months of angina pectoris, congestive heart failure
- HIV infection;
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 |
|---|---|---|
| nanoparticle albumin-bound paclitaxel/carboplatinAlso: paclitaxel /carboplatinNeoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin vs. paclitaxel /carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung: | Drug | nanoparticle albumin-bound paclitaxel |
Primary outcome
Tumor ORR and Number of Adverse Events
Time frame: From date of randomization until the date of progression, assessed up to 2 months
1 secondary outcome
PFS
Time frame: From date of surgery until the date of first documented progression, assessed up to 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
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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.
jianxing he, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
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 nanoparticle albumin-bound paclitaxel/carboplatin in people with Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical 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 2 inclusion and 9 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 7 Jun 2013. 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 jianxing he, MD (+86-02-83062808, hejx@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor ORR and Number of Adverse Events (time frame: From date of randomization until the date of progression, assessed up to 2 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 7 Jun 2013.