Individualized Adaptive Radiotherapy Based on PET/CT and IMRT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
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)
1 other identifier
interventional
400
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2015
Typical duration for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 29, 2016
CompletedFirst Posted
Study publicly available on registry
June 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 3, 2016
May 1, 2016
2.6 years
May 29, 2016
May 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
24 months
Secondary Outcomes (3)
Progression free survival
24 months
Objective response rate
24 months
local control rate
24 months
Study Arms (2)
Individualized Adaptive radiotherapy
EXPERIMENTALGTV 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 INTERVENTION2 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Province Cancer Hospital
Fuzhou, Fujian, 350008, China
the First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Liuzhou worker's hospital
Liuchow, Guangxi, China
Fourth hospital of hebei medical university
Shijiazhuang, Hebei, China
the second Hospital of hebei medical University
Shijiazhuang, Hebei, China
The Affiliated tumour Hospital of haerbin Medical University
Haerbin, Heilongjiang, China
The Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hubei Provincial Renmin Hospital
Wuhan, Hubei, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Qianfoshan Hospital of Shandong
Jinan, Shandong, 250117, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
The affiliated hospital of qingdao university
Qingdao, Shandong, China
Teng Zhou Central People's Hospital
Tengzhou, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Xijing hopital
Xi’an, Shanxi, China
the Affiliated Hospital of southwest medicalUniversity
Luzhou, Sichuan, China
The Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
the First Affiliated Hospital of wenzhou medical University
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shuanghu Yuan, Ph.D ， M.D
Shandong Cancer Hospital and Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- president
Study Record Dates
First Submitted
May 29, 2016
First Posted
June 3, 2016
Study Start
May 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
June 3, 2016
Record last verified: 2016-05