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High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598517
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Description
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Brief Summary:
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced non-small lung cancer.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Radiation: high dose chemoradiotherapy Not Applicable

Detailed Description:
Local failure remains high in patients with locoregionally advanced non-small lung cancer. Given that a biological equivalent dose (BED)more than 100 Gy yields approximately a local control rate of 90% in early-stage non-small lung cancer, this BED or ever higher is logically required to control local disease for locally advanced non-small lung cancer. However, dose escalation is limited by radiation-related toxicity. Use of hyperfractionated radiation Therapy boost to residual metabolic disease as defined by positron emission tomography and computed tomography (PET/CT) immediately after standard chemoradiotherapy (SCRT) using image-guided (IG) IMRT could potentially improve local control and perhaps survival
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensity-modulated Hyperfractionated Radiotherapy Boost to Residual Metabolic Disease Following Standard Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: high dose chemoradiotherapy
all eligible patients receive image-guided intensity-modulated radiotherapy 60 Gy in 30 fractions over 6 weeks and concurrent weekly paclitaxel and cisplatin，followed by hyperfractionated intensity-modulated radiotherapy boost to residual metabolic disease concurrent with the same chemotherapy regimen, followed by adjuvant chemotherapy 6 weeks after completion of radiation therapy.
 Radiation: high dose chemoradiotherapy

Radiation therapy: 60 Gy at 2 Gy/Fx/d over 6 weeks, immediately followed by 28.8 Gy in 24 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 88.8 Gy.

concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 2 and paclitaxel 45 mg/m2 over the duration (8 weeks) of radiation therapy.

Adjuvant chemotherapy is planned 6 weeks after high dose chemoradiation.


Outcome Measures
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Primary Outcome Measures :
  1. overall survival rate [ Time Frame: 2 year ]
    survival time was measured from the date of study enrollment to the date of death or last follow-up


Secondary Outcome Measures :
  1. toxicities [ Time Frame: 2 year ]
    Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
  • Age 1 8-75.
  • Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2.
  • Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
  • No prior radiation to the thorax that would overlap with the current treatment field.
  • Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </ =1 .5 times ULN.
  • A signed informed consent must be obtained prior to therapy.
  • Induction chemotherapy is allowed.
  • Life expectancy more than 3 months

Exclusion Criteria:

  • Patients with any component of small cell lung carcinoma are excluded from this study.
  • Patients with evidence of a malignant pleural or pericardial effusion are excluded.
  • Prior radiotherapy that would overlap the radiation fields.
  • Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
  • Known hypersensitivity to paclitaxel.
  • Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
  • Conditions precluding medical follow-up and protocol compliance
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598517


Contacts
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Contact: Ningning Cheng, MD 37798364 ext 8119 ningcnn@163.com
Contact: Yong Liu, MD 37798364 drliuyrt@163.com

Locations
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China, Shanghai
Shanghai Genernal Hospital Recruiting
Shanghai, Shanghai, China, 210000
Contact: Ningning Cheng    37798364 ext 8119    ningcnn@163.com   
Contact: yong Liu    37798364 ext 8110    drliuyrt@163.com   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Director: Tingfeng Chen, MD Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
More Information
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Responsible Party: Chen tingfeng, director, department of radiation, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03598517    
Other Study ID Numbers: SGH201816
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms