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Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in 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: NCT03699033
Recruitment Status : Withdrawn (No patients available)
First Posted : October 9, 2018
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Stephanie Smiddy, University of Toledo Health Science Campus

Tracking Information
First Submitted Date  ICMJE October 3, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date November 5, 2020
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv5.0) [ Time Frame: During and within 90 days of radiation therapy ]
Acute toxicities (toxicity during and within 90 days of radiation therapy) and delayed toxicities will be measured using CTCAE criteria, version 5.0. Acute toxicities are defined as those toxicities occurring during and within 90 days from the completion of radiotherapy and delayed toxicities are those that develop at least 90 days after the last dose of radiation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • Progression-free survival [ Time Frame: year 0 - year 2 ]
    Progression-free survival will be measured from the last day of radiation treatment until evidence of local or distant disease progression.
  • Overall Survival [ Time Frame: year 0 - year 5 ]
    Overall survival will be measured from the last day of radiation treatment until death.
  • Local control [ Time Frame: year 0 - year 2 ]
    Assessment of local control after treatment with radiotherapy combined with Carboplatin and Placlitaxel
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase II Trial of Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined With Carboplatin and Paclitaxel for Subjects With Stage IIIA or IIIB Non-Small Cell Lung Cancer
Brief Summary Single center, single arm, Phase II study designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects.
Detailed Description

This study is designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects.

Hypofractionated IMRT allows escalation of the biological effective dose (BED) to the tumor and reduces the radiation treatment duration to 5 weeks. Increasing the BED without protracting the RT course may be a more effective means of dose escalation than simply increasing the total dose but using only 2 Gy/fraction, as was tested in RTOG 0617.

Investigators require the use of advanced treatment planning techniques, including 4D CT simulation, volume delineation utilizing PET/CT to identify gross disease and IMRT to minimize the total volume of normal tissue receiving a high dose of radiation.

As minimal published work has evaluated hypofractionated RT regimens for Stage III NSCLC with concurrent chemotherapy, investigators selected a moderately escalated dose/fraction of 2.5 Gy for evaluation in combination with concurrent carboplatin and paclitaxel.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • Radiation: 2.5 Gy/fraction
    Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined with Carboplatin and Paclitaxel
  • Drug: Carboplatin

    The doses of chemotherapy to be given concurrently with conformal radiotherapy will be weekly paclitaxel (45 mg/m2) and carboplatin (AUC=2), respectively.

    Consolidation chemotherapy with 2 cycles of carboplatin (AUC=6) and paclitaxel (200 mg/m2) should be administered following completion of concurrent chemoradiation.

  • Drug: Paclitaxel

    The doses of chemotherapy to be given concurrently with conformal radiotherapy will be weekly paclitaxel (45 mg/m2) and carboplatin (AUC=2), respectively.

    Consolidation chemotherapy with 2 cycles of carboplatin (AUC=6) and paclitaxel (200 mg/m2) should be administered following completion of concurrent chemoradiation.

Study Arms  ICMJE Experimental: Radiation
2.5 Gy/Fraction
Interventions:
  • Radiation: 2.5 Gy/fraction
  • Drug: Carboplatin
  • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 3, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
50
Actual Study Completion Date  ICMJE October 1, 2020
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC).
  • Stage IIIA subjects who are considered eligible for resection following neoadjuvant chemoradiation are eligible for this study.
  • No PET/CT evidence of metastatic disease.
  • An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons.
  • If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible.
  • Subjects must have measurable or evaluable disease.
  • No prior thoracic radiotherapy.
  • Age > 18 years at time of registration.
  • ECOG Performance Status of 0-2 (Karnofsky performance scale ≥ 60).
  • Hgb > 9 g/dL; ANC (absolute neutrophil count) > 1500/µl; platelets > 100,000 mcL.
  • Subjects must sign study-specific informed consent form prior to registration.
  • Radiation therapy and chemotherapy must start within 4 weeks of study enrollment.

Exclusion Criteria:

  • Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
  • Active connective tissue disorders, such as active lupus or scleroderma.
  • Known Acquired Immune Deficiency (HIV (+)/AIDS).
  • Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regiment to harm nursing infants. Women of childbearing potential must agree to use medically approved and adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03699033
Other Study ID Numbers  ICMJE 202923
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Stephanie Smiddy, University of Toledo Health Science Campus
Original Responsible Party Krishna Reddy, MD, PhD, University of Toledo Health Science Campus, Principal Investigator
Current Study Sponsor  ICMJE Stephanie Smiddy
Original Study Sponsor  ICMJE Krishna Reddy, MD, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Toledo
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP