Lung NeoplasmsPhase 3NCT02790190
Individualized Adaptive Radiotherapy Based on PET/CT and IMRT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 3 study testing Radiotherapy dose in people with Lung Neoplasms, run by Shandong Cancer Hospital and Institute at 24 sites in China.
Trial summary
This is a perspective, multicenter,randomized controlled trial to compare the efficacy and safety of radiotherapy Based on PET/CT and IMRT combined with concurrent chemotherapy in patients with locally advanced non small cell lung cancer . Analyses of overall survival (OS) will be done as defined in the protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Radiotherapy dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 24 sitesChina
- Study dates
- May 2015to Dec 2017
- Phase
- Phase 3
- 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
- Histologically or cytologically proven non-small cell lung cancer.
- Patients must be clinical AJCC stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease; non-operable disease will be determined by a multidisciplinary treatment team.
- Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible if a definitive course of daily fractionated RT is planned.
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination, including documentation of weight, within 2 weeks prior to registration;
- CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration;
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- CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration;
- Pulmonary function tests, including DLCO, within 6 weeks prior to registration; patients must have FEV1 ≥ 1.2 Liter or ≥ 50% predicted without bronchodilator;
- Zubrod Performance Status 0-1 within 2 weeks prior to registration;
- Age ≥ 18;
- Able to tolerate PET/CT imaging required to be performed at an ACR Imaging Core Lab qualified facility;
- CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function;
- Serum creatinine within normal institutional limits or a creatinine clearance ≥ 60 ml/min within 2 weeks prior to registration;
- The patient must provide study-specific informed consent prior to study entry.
Who cannot join
- Any component of small cell lung carcinoma.
- Evidence of a malignant pleural or pericardial effusion .
- Prior invasive malignancy (except nonmelanomatous skin cancer) in 3 years ;
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
- Severe, active co-morbidity, defined as follows:
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- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing to use medically acceptable forms of contraception.
- Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) ;
- Patients with T4 disease with radiographic evidence of massive invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites, 24 recruiting
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Lvhua Wang, 13601283715, wlhwq@yahoo.com
Lvhua Wang
- Not yet recruiting
Fujian Province Cancer Hospital
Fuzhou, Fujian, 350008
Jiancheng Li, PhD, 8613906900190, jianchengli6@126.com
- Recruiting
The Affiliated tumour Hospital of haerbin Medical University
Haerbin, Heilongjiang
xiangying xu
- Not yet recruiting
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006
Shenglin Ma, PhD, 8613588799118, mashenglin@medmail.com.cn
- Not yet recruiting
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang
Senxiang Yan, yansenxiang@zju.edu.cn
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
YAPING XU, xuyaping1207@gmail.com
- Not yet recruiting
Qianfoshan Hospital of Shandong
Jinan, Shandong, 250117
Jiandong Zhang, 13583123486
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong
Shuanghu Shuanghu, 13853106916, yuanshuanghu@sina.com
Shuanghu Shuanghu
- Not yet recruiting
Liuzhou worker's hospital
Liuzhou, Guangxi
Dongning Huang
- Not yet recruiting
the Affiliated Hospital of southwest medicalUniversity
Luzhou, Sichuan
jingbo wu
- Not yet recruiting
The affiliated hospital of qingdao university
Qingdao, Shandong
haijun lu
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
xiaolong Fu, 13651635103@126.com
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Guang Li, 13804058616, 13804058616@163.com
Jun Dang, 13898150850, dangjunsy@163.com
- Not yet recruiting
Fourth hospital of hebei medical university
Shijiazhuang, Hebei
jun wang
- Not yet recruiting
the second Hospital of hebei medical University
Shijiazhuang, Hebei
xiaoying xue
- Not yet recruiting
Teng Zhou Central People's Hospital
Tengzhou, Shandong
Kaixian Zhang, kaixianzhang@aliyun.com
- Not yet recruiting
The Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Ruozheng Wang, wrz8526@163.com
- Not yet recruiting
the First Affiliated Hospital of wenzhou medical University
Wenzhou, Zhejiang
congying xie
- Not yet recruiting
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Gang Wu, PhD, 8613871240042, wugangzr@yahoo.com.cn
- Not yet recruiting
Hubei Provincial Renmin Hospital
Wuhan, Hubei
qibin song
- Not yet recruiting
Xijing hopital
Xi’an, Shanxi
Mei Shi, 214696138@qq.com
- Not yet recruiting
the First Affiliated Hospital of Xiamen University
Xiamen, Fujian
qin lin, linqin05@163.com
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
yipeng song
- Not yet recruiting
The Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan
Hong Ge, gehong666@126.com
About this study
Official title: Phase III Study of Individualized Adaptive Radiotherapy Based on PET/CT and 3DCRT/IMRT in Combination With Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
This is a perspective, multicenter,randomized controlled trial to compare the efficacy and safety of radiotherapy Based on PET/CT and IMRT combined with concurrent chemotherapy in patients with locally advanced non small cell lung cancer . Analyses of overall survival (OS) will be done as defined in the protocol.
Read the detailed description
https://register.clinicaltrials.gov/prs/app/template/Home.vm?uid=U000184Z\&ts=76\&sid=S0006AP2\&cx=r0ratc
- Conditions
- Lung Neoplasms
- Being tested
- Radiotherapy dose
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy doseOther
| Study group | Role | What they receive |
|---|---|---|
| Individualized Adaptive radiotherapy | Experimental | GTV dose per fraction will be 2.2-2.4 y per fraction for 20 fractions and PTV dose per fraction will be 2.0 Gy per fraction.Perform PET/CT before radiotherapy and at 36 Gy for treatment response assessment and adaptive plan.Adaptive plan treated at 2.2-3.8 Gy per fraction for GTV and 2.0 Gy for PTV in the final 10 fractions. Receives: Other: Radiotherapy dose |
| Conventional radiotherapy | No intervention | 2 Gy per fraction for all patient,perform PET/CT before radiotherapy and at 40 Gy for treatment response assessment .Continue treatment to a total dose of 60 Gy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 24 months
Secondary outcomes (3)
Progression free survival
Measured: 24 months
Objective response rate
Measured: 24 months
local control rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2017 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
- Investigators
- Shuanghu Yuan, Ph.D ， M.D, Study director, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790190
- Sponsor's protocol ID
- CRTOG1601
- Status last verified
- May 2016
- First submitted
- 29 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Individualized Adaptive Radiotherapy Based on PET/CT and 3DCRT/IMRT in Combination With Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02790190
- Acronym / sponsor ID
- CRTOG1601
- Conditions
- Lung Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Jun 2016 (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.
This is a perspective, multicenter,randomized controlled trial to compare the efficacy and safety of radiotherapy Based on PET/CT and IMRT combined with concurrent chemotherapy in patients with locally advanced non small cell lung cancer . Analyses of overall survival (OS) will be done as defined in the protocol.
Detailed description
https://register.clinicaltrials.gov/prs/app/template/Home.vm?uid=U000184Z\&ts=76\&sid=S0006AP2\&cx=r0ratc
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Adaptive radiotherapy | Experimental | Other: Radiotherapy doseGTV dose per fraction will be 2.2-2.4 y per fraction for 20 fractions and PTV dose per fraction will be 2.0 Gy per fraction.Perform PET/CT before radiotherapy and at 36 Gy for treatment response assessment and adaptive plan.Adaptive plan treated at 2.2-3.8 Gy per fraction for GTV and 2.0 Gy for PTV in the final 10 fractions. |
| Conventional radiotherapy | No intervention | –2 Gy per fraction for all patient,perform PET/CT before radiotherapy and at 40 Gy for treatment response assessment .Continue treatment to a total dose of 60 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically proven non-small cell lung cancer.
- Patients must be clinical AJCC stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease; non-operable disease will be determined by a multidisciplinary treatment team.
- Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible if a definitive course of daily fractionated RT is planned.
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- Serum creatinine within normal institutional limits or a creatinine clearance ≥ 60 ml/min within 2 weeks prior to registration;
Key exclusion criteria (10 listed)
- Any component of small cell lung carcinoma.
- Evidence of a malignant pleural or pericardial effusion .
- Prior invasive malignancy (except nonmelanomatous skin cancer) in 3 years ;
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
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 |
|---|---|---|
| Radiotherapy dose | Other | Individualized Adaptive radiotherapy |
Primary outcome
Overall survival
Time frame: 24 months
3 secondary outcomes
Progression free survival
Time frame: 24 months
Objective response rate
Time frame: 24 months
local control rate
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
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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.
Shuanghu Yuan, Ph.D ， M.D study director
Shandong Cancer Hospital and Institute
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy dose in people with Lung Neoplasms, run by Shandong Cancer Hospital and Institute at 24 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 14 inclusion and 10 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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jinming Yu, Ph.D ， M.D (13806406293, sdyujinming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 24 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 3 Jun 2016; AzTrials last refreshed its copy on 5 Nov 2026.