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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Lung Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Radiotherapy dose

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Radiotherapy dose

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jinming Yu

president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuanghu Yuan, Ph.D ， M.D

Role: STUDY_DIRECTOR

Shandong Cancer Hospital and Institute

Locations

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