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

May 29, 2016 updated by: Jinming Yu, Shandong Cancer Hospital and Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Fujian
      • Fuzhou, Fujian, China, 350008
        • Not yet recruiting
        • Fujian Province Cancer Hospital
        • Contact:
      • Xiamen, Fujian, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Guangxi
      • Liuzhou, Guangxi, China
        • Not yet recruiting
        • Liuzhou Worker's Hospital
        • Contact:
          • Dongning Huang
    • Hebei
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • Fourth Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
    • Heilongjiang
      • Haerbin, Heilongjiang, China
        • Recruiting
        • The Affiliated tumour Hospital of haerbin Medical University
        • Contact:
          • xiangying xu
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • The Affiliated Cancer Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Hubei Provincial Renmin Hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • The First Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital and Institute
        • Contact:
        • Principal Investigator:
          • Shuanghu Shuanghu
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Qianfoshan Hospital of Shandong
        • Contact:
          • Jiandong Zhang
          • Phone Number: 13583123486
      • Qingdao, Shandong, China
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • haijun lu
      • Tengzhou, Shandong, China
      • Yantai, Shandong, China
        • Not yet recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
          • yipeng song
    • Shanghai
      • Shanghai, Shanghai, China
    • Shanxi
      • Xi'an, Shanxi, China
    • Sichuan
      • Luzhou, Sichuan, China
        • Not yet recruiting
        • the Affiliated Hospital of southwest medicalUniversity
        • Contact:
          • jingbo wu
    • Xinjiang
      • Wulumuqi, Xinjiang, China
        • Not yet recruiting
        • The Affiliated Tumor Hospital of Xinjiang Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Not yet recruiting
        • The First People's Hospital of Hangzhou
        • Contact:
      • Hangzhou, Zhejiang, China
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital of Medical School of Zhejiang University
        • Contact:
      • Wenzhou, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • congying xie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Individualized Adaptive radiotherapy
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.
Other: Radiotherapy dose
NO_INTERVENTION: Conventional radiotherapy
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 24 months
24 months
Objective response rate
Time Frame: 24 months
24 months
local control rate
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Investigators

  • Study Director: Shuanghu Yuan, Ph.D ， M.D, Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

May 29, 2016

First Submitted That Met QC Criteria

May 29, 2016

First Posted (ESTIMATE)

June 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2016

Last Update Submitted That Met QC Criteria

May 29, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRTOG1601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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