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

Phase 3

• Conditions: Lung Neoplasms
• Interventions: Other: Radiotherapy dose

• Registration Number: NCT02790190
• Lead Sponsor: Shandong Cancer Hospital and Institute

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

Study Timeline

• Study Start: 2015-05
• Status Verified: 2016-05
• Study First Submitted: 2016-05-29
• Study First Submitted QC: 2016-05-29
• Last Update Submitted: 2016-05-29
• Study First Posted: 2016-06-03
• Last Update Posted: 2016-06-03
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized Adaptive radiotherapy	Radiotherapy dose	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	24 months

Secondary Outcome Measures

Name	Time	Method
local control rate	24 months
Progression free survival	24 months
Objective response rate	24 months

Trial Locations

Locations (24)

Liuzhou worker's hospital; 🇨🇳 Liuzhou, Guangxi, China

Fourth hospital of hebei medical university; 🇨🇳 Shijiazhuang, Hebei, China

the second Hospital of hebei medical University; 🇨🇳 Shijiazhuang, Hebei, China

Qianfoshan Hospital of Shandong; 🇨🇳 Jinan, Shandong, China

Shandong Cancer Hospital and Institute; 🇨🇳 Jinan, Shandong, China

Teng Zhou Central People's Hospital; 🇨🇳 Tengzhou, Shandong, China

Yantai Yuhuangding Hospital; 🇨🇳 Yantai, Shandong, China

Xijing hopital; 🇨🇳 Xi'an, Shanxi, China

The First People's Hospital of Hangzhou; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

the First Affiliated Hospital of wenzhou medical University; 🇨🇳 Wenzhou, Zhejiang, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Fujian Province Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

the First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, 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, China

The affiliated hospital of qingdao university; 🇨🇳 Qingdao, Shandong, China

Hubei Provincial Renmin Hospital; 🇨🇳 Wuhan, Hubei, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

the Affiliated Hospital of southwest medicalUniversity; 🇨🇳 Luzhou, Sichuan, China

The Affiliated Tumor Hospital of Xinjiang Medical University; 🇨🇳 Wulumuqi, Xinjiang, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Medical School of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China