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PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03099577
Collaborator
(none)
34
Enrollment
1
Location
7
Arms
17.9
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Radiation: radiochemotherapy 1
  • Radiation: radiochemotherapy 2
  • Radiation: radiochemotherapy 3
  • Radiation: radiochemotherapy 4
  • Radiation: radiochemotherapy 5
  • Radiation: radiochemotherapy 6
  • Radiation: radiochemotherapy 7
 N/A

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.

Study Design

Study Type:
Interventional
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 :
Jan 2, 2017
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • concurrent chemoradiotherapy regimen 7

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose [1 year]

      Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity

    Secondary Outcome Measures

    1. Time to Local Failure [2 years]

      Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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/mm3,absolute granulocyte count (AGC) ≥2 × 109 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the Ethic Committee of Shanghai General Hospital Shanghai China

    Sponsors and Collaborators

    • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    Investigators

    • Principal Investigator: Tingfeng Chen, MD, the ethic committee of shanghai genernal hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Apr 4, 2017
    Last Update Posted:
    May 3, 2019
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of May 3, 2019