Lung Adenocarcinoma Patients With Postoperative in pN2NCT02132143
Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2
A study testing intensity-modulated radiation in people with Lung Adenocarcinoma Patients With Postoperative in pN2, run by Hui Lin at 1 site in China.
Trial summary
The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Adenocarcinoma Patients With Postoperative in pN2
- What is being tested?
- intensity-modulated radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2017
- Phase
- Interventional
- 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
- Clinical diagnosis of Lung adenocarcinoma
- Postoperative staging pN2 period
- Voluntary participation and informed consent
- Age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy
- performance status( PS) score 0-2.
- Hemoglobin ≥ 80 g / L, white blood cell ≥ 4 × 109 / L, platelets ≥ 100 × 109 / L.
Show all 9Show fewer
- Liver function: alanine aminotransferase (ALAT), aspartate transaminase (ASAT) <upper limit of normal (ULN) of 1.5 times, bilirubin <1.5 × ULN.
- Renal function: serum creatinine <1.5 × ULN.
- Compliance, and can be regular follow-up, voluntary compliance with study requirements
Who cannot join
- Do not meet the inclusion criteria
- There is evidence of distant metastases
- Suffered from other malignancies in five years
- Within the past January subjects received other drug trials
- Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
- Severe lung or heart disease, a history
Show all 11Show fewer
- Refuses or is unable to sign informed consent to participate in trials
- The abuse of drugs or alcohol addicts.
- Patients with difficult to control bacterial, viral, fungal infections
- Having a personality or mental disorders, without civil capacity or restricted civil capacity.
- Being pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530021
Hui Lin, 8613878133266, linhui33266@sina.com
About this study
The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients.
- Being tested
- intensity-modulated radiation
- Keywords
- Lung adenocarcinoma, Concurrent chemoradiotherapy, Sequential chemoradiotherapy, Progression-free survival
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensity-modulated radiationRadiation
For concurrent chemoradiotherapy, the intensity-modulated radiation therapy(IMRT)will be given at the first day of therapy,total dose of 5000cGy～6000cGy/5-6 Weeks.
intensity-modulated radiationRadiation
For sequential chemoradiotherapy,the intensity-modulated radiation will(IMRT) will be given when patients received adjuvant chemotherapy for four cycles,total dose of 5000cGy～6000cGy/5-6 Weeks.
| Study group | Role | What they receive |
|---|---|---|
| Progression-free survival&Concurrent chemoradiotherapy | Experimental | The first day of radiotherapy given pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, two cycles of chemotherapy given during radiotherapy; then continue to give two cycles of consolidation chemotherapy, 21 days as a cycle.
Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W. Receives: Radiation: intensity-modulated radiation |
| Progression-free survival&sequential chemoradiotherapy | Active comparator | Patients received adjuvant chemotherapy for four cycles,pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, 21 days as a cycle.Then accept the Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W. Receives: Radiation: intensity-modulated radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
01/01/2014-06/01/2016
Measured: two and a half years
Secondary outcomes (1)
Overall survival
01/01/2014-01/01-2016
Measured: two and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Adenocarcinoma Patients With Postoperative in pN2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Lin, People's Hospital of Guangxi Zhuang Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132143
- Sponsor's protocol ID
- LH-2014-XW
- Status last verified
- May 2015
- First submitted
- 2 May 2014
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2
- ClinicalTrials.gov ID
- NCT02132143
- Acronym / sponsor ID
- LH-2014-XW
- Keywords
- Lung adenocarcinoma, Concurrent chemoradiotherapy, Sequential chemoradiotherapy, Progression-free survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hui LinUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 7 May 2014 (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.
The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progression-free survival&Concurrent chemoradiotherapy | Experimental | Radiation: intensity-modulated radiationThe first day of radiotherapy given pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, two cycles of chemotherapy given during radiotherapy; then continue to give two cycles of consolidation chemotherapy, 21 days as a cycle. Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W. |
| Progression-free survival&sequential chemoradiotherapy | Active comparator | Radiation: intensity-modulated radiationPatients received adjuvant chemotherapy for four cycles,pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, 21 days as a cycle.Then accept the Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of Lung adenocarcinoma
- Postoperative staging pN2 period
- Voluntary participation and informed consent
- Age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy
- performance status( PS) score 0-2.
Key exclusion criteria (11 listed)
- Do not meet the inclusion criteria
- There is evidence of distant metastases
- Suffered from other malignancies in five years
- Within the past January subjects received other drug trials
- Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
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 |
|---|---|---|
| intensity-modulated radiationFor concurrent chemoradiotherapy, the intensity-modulated radiation therapy(IMRT)will be given at the first day of therapy,total dose of 5000cGy～6000cGy/5-6 Weeks. | Radiation | Progression-free survival&Concurrent chemoradiotherapy |
| intensity-modulated radiationFor sequential chemoradiotherapy,the intensity-modulated radiation will(IMRT) will be given when patients received adjuvant chemotherapy for four cycles,total dose of 5000cGy～6000cGy/5-6 Weeks. | Radiation | Progression-free survival&sequential chemoradiotherapy |
Primary outcome
progression-free survival
Time frame: two and a half years
01/01/2014-06/01/2016
1 secondary outcome
Overall survival
Time frame: two and a half years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensity-modulated radiation in people with Lung Adenocarcinoma Patients With Postoperative in pN2, run by Hui Lin 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 9 inclusion and 11 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 6 May 2015. 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.
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 Hui Lin, Doctor (8613878133622, linhui33266@sina.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: two and a half years). 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 6 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.