Carcinoma, Non-Small-Cell LungPhase 2NCT01494415
Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer
A Phase 2 study testing Paclitaxel for Injection（Albumin Bound）, carboplatin and thoracic radiation therapy in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Squamous Cell, run by First People's Hospital of Hangzhou at 2 sites in China.
Trial summary
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell
- What is being tested?
- Paclitaxel for Injection（Albumin Bound）, carboplatin and thoracic radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2012to Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Previously untreated, histological documented, inoperable stage IIIA or IIIB squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
- Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
- Weight loss ≦ 5% in the previous six months.
- Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
- Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
- Patients must sign a study-specific informed consent form prior to study entry.
Who cannot join
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- Previous chemotherapy or previous biologic response modifiers for current lung cancer.
- Patient has previously had thoracic radiation therapy.
- Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
- Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
- History of significant neurological or mental disorder, including seizures or dementia.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002
Bing Xia, MD, 0571-56006035, bxia_hzch@hotmail.com
Bing Xia, MD
- Active, not recruiting
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006
About this study
Official title: A Phase II Study of Concurrent Nab-Paclitaxel, Carboplatin and Thoracic Radiotherapy in Local Advanced Squamous Cell Lung Cancer
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. The regimen of weekly nab-paclitaxel, carboplatin and concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung cancer may have promising result.
Read the detailed description
This study was conducted to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 60mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed. Two cycles of consolidation therapy with full dose nab-paclitaxel (260 mg/m2 on day 1) and carboplatin (AUC 6 on day 1) every 21 day will be delivered.
- Being tested
- Paclitaxel for Injection（Albumin Bound）, carboplatin, thoracic radiation therapy
- Keywords
- Squamous Cell Lung Cancer, radiation therapy, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel for Injection（Albumin Bound）Drug
Also called Abraxane®
concurrent: 60 mg/m2, IV, weekly; consolidation: 260 mg/m2, IV, every 3 weeks
carboplatinDrug
concurrent: AUC 2, IV, weekly; consolidation: AUC 6, IV, every 3 weeks
thoracic radiation therapyRadiation
66 Gy in 33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
| Study group | Role | What they receive |
|---|---|---|
| chemoradiotherapy | Experimental | This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy. Receives: Drug: Paclitaxel for Injection（Albumin Bound）; Drug: carboplatin; Radiation: thoracic radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response rate
Measured: one month after the end of all treatment
Secondary outcomes (3)
progression-free survival
Measured: 2 years from patient enrollment
overall survival
Measured: 2 years from patient enrollment
esophagitis
acute esophagitis of Grade III and above
Measured: 6 mouths from the initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startJul 2012
- Primary completionJul 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shenglin Ma, First People's Hospital of Hangzhou
- Investigators
- Shenglin Ma, MD, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494415
- Sponsor's protocol ID
- HZFH CA11-01
- Status last verified
- Dec 2015
- First submitted
- 14 Dec 2011
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Concurrent Nab-Paclitaxel, Carboplatin and Thoracic Radiotherapy in Local Advanced Squamous Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01494415
- Acronym / sponsor ID
- HZFH CA11-01
- Keywords
- Squamous Cell Lung Cancer, radiation therapy, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 19 Dec 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.
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. The regimen of weekly nab-paclitaxel, carboplatin and concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung cancer may have promising result.
Detailed description
This study was conducted to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 60mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed. Two cycles of consolidation therapy with full dose nab-paclitaxel (260 mg/m2 on day 1) and carboplatin (AUC 6 on day 1) every 21 day will be delivered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemoradiotherapy | Experimental | Drug: Paclitaxel for Injection（Albumin Bound）, Drug: carboplatin, Radiation: thoracic radiation therapyThis is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Previously untreated, histological documented, inoperable stage IIIA or IIIB squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
- Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
- Weight loss ≦ 5% in the previous six months.
- Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
Key exclusion criteria (6 listed)
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- Previous chemotherapy or previous biologic response modifiers for current lung cancer.
- Patient has previously had thoracic radiation therapy.
- Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
- Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
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 |
|---|---|---|
| Paclitaxel for Injection（Albumin Bound）Also: Abraxane®concurrent: 60 mg/m2, IV, weekly; consolidation: 260 mg/m2, IV, every 3 weeks | Drug | chemoradiotherapy |
| carboplatinconcurrent: AUC 2, IV, weekly; consolidation: AUC 6, IV, every 3 weeks | Drug | chemoradiotherapy |
| thoracic radiation therapy66 Gy in 33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed | Radiation | chemoradiotherapy |
Primary outcome
tumor response rate
Time frame: one month after the end of all treatment
3 secondary outcomes
progression-free survival
Time frame: 2 years from patient enrollment
overall survival
Time frame: 2 years from patient enrollment
esophagitis
Time frame: 6 mouths from the initiation of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
Related trials for Carcinoma, Non-Small-Cell Lung
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)
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
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, 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.
Shenglin Ma, MD principal investigator
First People's Hospital of Hangzhou
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel for Injection（Albumin Bound）, carboplatin and thoracic radiation therapy in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Squamous Cell, run by First People's Hospital of Hangzhou at 2 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 7 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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 Bing Xia, MD, PhD (86 18857110928, bxia_hzch@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response rate (time frame: one month after the end of all treatment). 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 Dec 2015.