Clinical trial NCT02790190: Individualized Adaptive Radiotherapy Based on PET/CT and IMRT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Neoplasms
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: https://register.clinicaltrials.gov/prs/app/template/Home.vm?uid=U000184Z\&ts=76\&sid=S0006AP2\&cx=r0ratc

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically proven non-small cell lung cancer.
2. 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.
3. Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible if a definitive course of daily fractionated RT is planned.
4. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:

   1. History/physical examination, including documentation of weight, within 2 weeks prior to registration;
   2. CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration;
   3. CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration;
   4. Pulmonary function tests, including DLCO, within 6 weeks prior to registration; patients must have FEV1 ≥ 1.2 Liter or ≥ 50% predicted without bronchodilator;
   5. Zubrod Performance Status 0-1 within 2 weeks prior to registration;
   6. Age ≥ 18;
   7. Able to tolerate PET/CT imaging required to be performed at an ACR Imaging Core Lab qualified facility;
   8. CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function;
5. Serum creatinine within normal institutional limits or a creatinine clearance ≥ 60 ml/min within 2 weeks prior to registration;
6. The patient must provide study-specific informed consent prior to study entry.

Exclusion Criteria

1. Any component of small cell lung carcinoma.
2. Evidence of a malignant pleural or pericardial effusion .
3. Prior invasive malignancy (except nonmelanomatous skin cancer) in 3 years ;
4. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
6. 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.
7. Pregnancy or women of childbearing potential and men who are sexually active and not willing to use medically acceptable forms of contraception.
8. Poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) ;
9. 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.

Primary outcomes:
measure: Overall survival
timeFrame: 24 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 24 months
measure: Objective response rate
timeFrame: 24 months
measure: local control rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Fuzhou
country: China
facility: Fujian Province Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: the First Affiliated Hospital of Xiamen University
state: Fujian
city: Liuzhou
country: China
facility: Liuzhou worker's hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: Fourth hospital of hebei medical university
state: Hebei
city: Shijiazhuang
country: China
facility: the second Hospital of hebei medical University
state: Hebei
city: Haerbin
country: China
facility: The Affiliated tumour Hospital of haerbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The Affiliated Cancer Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Provincial Renmin Hospital
state: Hubei
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qianfoshan Hospital of Shandong
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
city: Qingdao
country: China
facility: The affiliated hospital of qingdao university
state: Shandong
city: Tengzhou
country: China
facility: Teng Zhou Central People's Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Xi'an
country: China
facility: Xijing hopital
state: Shanxi
city: Luzhou
country: China
facility: the Affiliated Hospital of southwest medicalUniversity
state: Sichuan
city: Wulumuqi
country: China
facility: The Affiliated Tumor Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: the First Affiliated Hospital of wenzhou medical University
state: Zhejiang
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Shuanghu Yuan, Ph.D ， M.D
role: STUDY_DIRECTOR
References: