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PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099577
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin & paclitaxel) in patients with stage III non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Radiation: radiochemotherapy 1 Radiation: radiochemotherapy 2 Radiation: radiochemotherapy 3 Radiation: radiochemotherapy 4 Radiation: radiochemotherapy 5 Radiation: radiochemotherapy 6 Radiation: radiochemotherapy 7 Not Applicable

Detailed Description:

Concurrent chemoradiotherapy is the standard of care for unresectable stage III NSCLC based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 60- Gy at -2 Gy/fraction for nearly four decades (60Gy), with local disease control rates of approximately 50% and a median overall survival of only 18 months.These results are suboptimal and more effective treatment regimens are needed.

We hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of PET/CT-directed Hyperfractionated Radiation Dose Escalation With Concurrent Weekly Carboplatin and Paclitaxel in Stage III Non-small Cell Lung Cancer
Actual Study Start Date : January 2, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: radiochemotherapy 1
Patients will be treated with radiation therapy 64.8 Gy
Radiation: radiochemotherapy 1
concurrent radiochemotherapy: radiotherapy dose level 1: 60 Gy at 2 Gy/Fx/d, then 4.8 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen 1

Experimental: radiochemotherapy 2
Patients will be treated with radiation therapy 69.6 Gy
Radiation: radiochemotherapy 2
concurrent radiochemotherapy: radiotherapy dose level 2: 60 Gy at 2 Gy/Fx/d, then 9.6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen 2

Experimental: radiochemotherapy 3
Patients will be treated with radiation therapy 74.4 Gy
Radiation: radiochemotherapy 3
concurrent radiochemotherapy: radiotherapy dose level 3: 60 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen 3

Experimental: radiochemotherapy 4
Patients will be treated with radiation therapy 79.2 Gy
Radiation: radiochemotherapy 4
concurrent radiochemotherapy: radiotherapy dose level 4: 60 Gy at 2 Gy/Fx/d, then 19.2 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen 4

Experimental: radiochemotherapy 5
Patients will be treated with radiation therapy 84 Gy
Radiation: radiochemotherapy 5
concurrent radiochemotherapy: radiotherapy dose level 5: 60 Gy at 2 Gy/Fx/d, then 4.8x5 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen 5

Experimental: radiochemotherapy 6
Patients will be treated with radiation therapy 88.8 Gy
Radiation: radiochemotherapy 6
concurrent radiochemotherapy: radiotherapy dose level 6: 60 Gy at 2 Gy/Fx/d, then 4.8x6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen 6

Experimental: radiochemotherapy 7
Patients will be treated with radiation therapy 93.6 Gy
Radiation: radiochemotherapy 7
concurrent radiochemotherapy: radiotherapy dose level 7: 60 Gy at 2 Gy/Fx/d, then 4.8x7 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen 7




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 1 year ]
    Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity


Secondary Outcome Measures :
  1. Time to Local Failure [ Time Frame: 2 years ]
    Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan



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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:

  1. Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
  2. Age 1 8-75.
  3. Zubrod performance status 0-2.
  4. Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
  5. No prior radiation to the thorax that would overlap with the current treatment field.
  6. 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.
  7. A signed informed consent must be obtained prior to therapy.
  8. Induction chemotherapy is allowed.
  9. Life expectancy more than 3 months.

Exclusion Criteria:

  1. Patients with any component of small cell lung carcinoma are excluded from this study.
  2. Patients with evidence of a malignant pleural or pericardial effusion are excluded.
  3. Prior radiotherapy that would overlap the radiation fields.
  4. 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.
  5. Known hypersensitivity to paclitaxel.
  6. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
  7. Acquired Immune Deficiency Syndrome.
  8. Conditions precluding medical follow-up and protocol compliance.

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): NCT03099577


Locations
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China
the Ethic Committee of Shanghai General Hospital
Shanghai, China
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Tingfeng Chen, MD the ethic committee of shanghai genernal hospital
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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: NCT03099577    
Other Study ID Numbers: SGH201708
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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