Non-Small Cell Lung CancerPhase 2NSCLCNCT00886678
A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)
A Phase 2 study testing pemetrexed, carboplatin and thoracic radiation in people with Non-Small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- pemetrexed, carboplatin and thoracic radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Jul 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)
- Presence of measurable disease by RECIST
- Inoperable stage IIIA or IIIB
- ECOG performance status 0-1
- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.
Who cannot join
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
- Women and men of childbearing potential who have no willing of employing adequate contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer
Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- pemetrexed, carboplatin, thoracic radiation
- Keywords
- Non-Small Cell Lung Cancer, pemetrexed, radiation
- 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.
pemetrexedDrug
500 mg/m2, IV, q 21 days x 2 cycles
carboplatinDrug
AUC=5,IV,q 21 days x 2 cycles
thoracic radiationRadiation
66 Gy over 33 fractions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients receiving pemetrexed, carboplatin and radiation therapy. Receives: Drug: pemetrexed; Drug: carboplatin; Radiation: thoracic radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response rate
Measured: Tumor assessments after completion of chemoradiotherapy and every 2 months
Secondary outcomes (4)
overall survival
Measured: baseline to date of death from any cause
time to progressive disease
Measured: baseline to measured progressive disease
the safety profile
Measured: every cycle
site of first failure in patients who develop progressive disease
Measured: baseline to measured progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (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 Zhejiang Cancer HospitalThe 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ma Sheng lin, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886678
- Sponsor's protocol ID
- ZhejiangCH01
- Acronym
- NSCLC
- Status last verified
- Mar 2010
- First submitted
- 31 Mar 2009
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00886678
- Acronym / sponsor ID
- NSCLC / ZhejiangCH01
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, pemetrexed, radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 23 Apr 2009 (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.
Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pemetrexed, Drug: carboplatin, Radiation: thoracic radiationpatients receiving pemetrexed, carboplatin and radiation therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)
- Presence of measurable disease by RECIST
- Inoperable stage IIIA or IIIB
- ECOG performance status 0-1
- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
Key exclusion criteria (5 listed)
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
- Women and men of childbearing potential who have no willing of employing adequate contraception
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 |
|---|---|---|
| pemetrexed500 mg/m2, IV, q 21 days x 2 cycles | Drug | 1 |
| carboplatinAUC=5,IV,q 21 days x 2 cycles | Drug | 1 |
| thoracic radiation66 Gy over 33 fractions | Radiation | 1 |
Primary outcome
tumor response rate
Time frame: Tumor assessments after completion of chemoradiotherapy and every 2 months
4 secondary outcomes
overall survival
Time frame: baseline to date of death from any cause
time to progressive disease
Time frame: baseline to measured progressive disease
the safety profile
Time frame: every cycle
site of first failure in patients who develop progressive disease
Time frame: baseline to measured progressive disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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.
Ma Sheng lin, MD principal investigator
Zhejiang Cancer 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 pemetrexed, carboplatin and thoracic radiation in people with Non-Small Cell Lung Cancer, run by Zhejiang Cancer Hospital 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 6 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: status not confirmed, as of the sponsor's last update on 24 Feb 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response rate (time frame: Tumor assessments after completion of chemoradiotherapy and every 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 24 Feb 2011.