Individualized Adaptive Radiotherapy Based on PET/CT and IMRT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Lung Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02790190
• Other study ID #: CRTOG1601
• Status: Recruiting
• Phase: Phase 3
• First received: May 29, 2016
• Last updated: May 29, 2016
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: Shandong Cancer Hospital and Institute
• Contact: Jinming Yu, Ph.D , M.D
• Phone: 13806406293
• Email: sdyujinming[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Other:
• Radiotherapy dose

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Fujian Province Cancer Hospital	Fuzhou	Fujian
China	The Affiliated tumour Hospital of haerbin Medical University	Haerbin	Heilongjiang
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou	Zhejiang
China	The First People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Qianfoshan Hospital of Shandong	Jinan	Shandong
China	Shandong Cancer Hospital and Institute	Jinan	Shandong
China	Liuzhou worker's hospital	Liuzhou	Guangxi
China	the Affiliated Hospital of southwest medicalUniversity	Luzhou	Sichuan
China	The affiliated hospital of qingdao university	Qingdao	Shandong
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Fourth hospital of hebei medical university	Shijiazhuang	Hebei
China	the second Hospital of hebei medical University	Shijiazhuang	Hebei
China	Teng Zhou Central People's Hospital	Tengzhou	Shandong
China	the First Affiliated Hospital of wenzhou medical University	Wenzhou	Zhejiang
China	Hubei Provincial Renmin Hospital	Wuhan	Hubei
China	Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The Affiliated Tumor Hospital of Xinjiang Medical University	Wulumuqi	Xinjiang
China	Xijing hopital	Xi'an	Shanxi
China	the First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	The Affiliated Cancer Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		24 months	Yes
Secondary	Progression free survival		24 months	Yes
Secondary	Objective response rate		24 months	Yes
Secondary	local control rate		24 months	Yes