Lung NeoplasmsPhase 2NCT00563160
Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small-cell Lung Cancer Before Surgery
A Phase 2 study testing gemcitabine, carboplatin and surgery in people with Lung Neoplasms, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- gemcitabine, carboplatin and surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- May 2005to Feb 2007
- 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
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven, newly diagnosed primary bronchogenic non-small cell lung cancer
- Measurable or evaluable tumour on chest X-ray or CT scan.
- No multiple ipsilateral or contralateral parenchymal tumours
- Stage I(exceptT1N0),II,IIIa disease as shown by PET-CT
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital
Hong Kong
Che Mun Poon, Dr
Chun Key Law, Dr
About this study
Official title: Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small Cell Lung Cancer Before Surgery
To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis
- Conditions
- Lung Neoplasms
- Being tested
- gemcitabine, carboplatin, surgery
- Keywords
- lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine, carboplatinDrug
surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological response rate
Measured: 12 months
Secondary outcomes (3)
progression-free survival
Measured: 18 months
overall survival
Measured: 18 months
quality of life measurements
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startMay 2005
- Study completionFeb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Eli Lilly and Company
- Investigators
- Siu Kie Au, Dr, Principal investigator, Department of Clinical Oncology, Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563160
- Sponsor's protocol ID
- (193-h)in QE/EC/I
- Other IDs
- HARECCTR0500015, 000904, B9E-IH-O333
- Status last verified
- Jul 2010
- First submitted
- 21 Nov 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small Cell Lung Cancer Before Surgery
- ClinicalTrials.gov ID
- NCT00563160
- Acronym / sponsor ID
- (193-h)in QE/EC/I
- Conditions
- Lung Neoplasms
- Keywords
- lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Eli Lilly and Company
- Study start
- May 2005
- Study completion
- Feb 2007 (estimated)
- First posted
- 26 Nov 2007 (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.
To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically proven, newly diagnosed primary bronchogenic non-small cell lung cancer
- Measurable or evaluable tumour on chest X-ray or CT scan.
- No multiple ipsilateral or contralateral parenchymal tumours
- Stage I(exceptT1N0),II,IIIa disease as shown by PET-CT
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| gemcitabine, carboplatin | Drug | – |
| surgery | Procedure or surgery | – |
Primary outcome
pathological response rate
Time frame: 12 months
3 secondary outcomes
progression-free survival
Time frame: 18 months
overall survival
Time frame: 18 months
quality of life measurements
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
Siu Kie Au, Dr principal investigator
Department of Clinical Oncology, Queen Elizabeth Hospital
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 gemcitabine, carboplatin and surgery in people with Lung Neoplasms, run by Hospital Authority, Hong Kong 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 0 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 Jul 2010. 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 Patricia Poon, Dr ((852) 2958 2310, pcm0806@netvigator.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological response rate (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 7 Jul 2010.