Back to resultsPET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiochemotherapy 1
radiochemotherapy 2
radiochemotherapy 3
radiochemotherapy 4
radiochemotherapy 5
radiochemotherapy 6
radiochemotherapy 7
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
- Age 1 8-75.
- Zubrod performance status 0-2.
- 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.
- Acquired Immune Deficiency Syndrome.
- Conditions precluding medical follow-up and protocol compliance.
Sites / Locations
- the Ethic Committee of Shanghai General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
radiochemotherapy 1
radiochemotherapy 2
radiochemotherapy 3
radiochemotherapy 4
radiochemotherapy 5
radiochemotherapy 6
radiochemotherapy 7
Arm Description
Patients will be treated with radiation therapy 64.8 Gy
Patients will be treated with radiation therapy 69.6 Gy
Patients will be treated with radiation therapy 74.4 Gy
Patients will be treated with radiation therapy 79.2 Gy
Patients will be treated with radiation therapy 84 Gy
Patients will be treated with radiation therapy 88.8 Gy
Patients will be treated with radiation therapy 93.6 Gy
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose
Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity
Secondary Outcome Measures
Time to Local Failure
Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan
Full Information
NCT ID
NCT03099577
First Posted
March 28, 2017
Last Updated
May 1, 2019
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03099577
Brief Title
PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
radiochemotherapy 1
Arm Type
Experimental
Arm Description
Patients will be treated with radiation therapy 64.8 Gy
Arm Title
radiochemotherapy 2
Arm Type
Experimental
Arm Description
Patients will be treated with radiation therapy 69.6 Gy
Arm Title
radiochemotherapy 3
Arm Type
Experimental
Arm Description
Patients will be treated with radiation therapy 74.4 Gy
Arm Title
radiochemotherapy 4
Arm Type
Experimental
Arm Description
Patients will be treated with radiation therapy 79.2 Gy
Arm Title
radiochemotherapy 5
Arm Type
Experimental
Arm Description
Patients will be treated with radiation therapy 84 Gy
Arm Title
radiochemotherapy 6
Arm Type
Experimental
Arm Description
Patients will be treated with radiation therapy 88.8 Gy
Arm Title
radiochemotherapy 7
Arm Type
Experimental
Arm Description
Patients will be treated with radiation therapy 93.6 Gy
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy 1
Other Intervention Name(s)
concurrent chemoradiotherapy regimen 1
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy 2
Other Intervention Name(s)
concurrent chemoradiotherapy regimen 2
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy 3
Other Intervention Name(s)
concurrent chemoradiotherapy regimen 3
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy 4
Other Intervention Name(s)
concurrent chemoradiotherapy regimen 4
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy 5
Other Intervention Name(s)
concurrent chemoradiotherapy regimen 5
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy 6
Other Intervention Name(s)
concurrent chemoradiotherapy regimen 6
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy 7
Other Intervention Name(s)
concurrent chemoradiotherapy regimen 7
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Description
Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to Local Failure
Description
Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
Age 1 8-75.
Zubrod performance status 0-2.
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.
Acquired Immune Deficiency Syndrome.
Conditions precluding medical follow-up and protocol compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tingfeng Chen, MD
Organizational Affiliation
the ethic committee of shanghai genernal hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Ethic Committee of Shanghai General Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer
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