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Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03699033
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Krishna Reddy, MD, PhD, University of Toledo Health Science Campus

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Radiation: 2.5 Gy/fraction Drug: Carboplatin Drug: Paclitaxel Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Radiation
2.5 Gy/Fraction
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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Overall Survival [ Time Frame: year 0 - year 5 ]
    Overall survival will be measured from the last day of radiation treatment until death.

  3. Local control [ Time Frame: year 0 - year 2 ]
    Assessment of local control after treatment with radiotherapy combined with Carboplatin and Placlitaxel



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03699033


Locations
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United States, Ohio
University of Toledo, Eleanor N. Dana Cancer Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Stephanie Smiddy, RN, BSN, CCRC    419-383-4000 ext 6962    stephanie.smiddy@utoledo.edu   
Principal Investigator: Krishna Reddy, MD, PhD         
Sponsors and Collaborators
Krishna Reddy, MD, PhD

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Responsible Party: Krishna Reddy, MD, PhD, Principal Investigator, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT03699033     History of Changes
Other Study ID Numbers: 202923
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Krishna Reddy, MD, PhD, University of Toledo Health Science Campus:
Radiation
NSCLC
Hypofractionated
Carboplatin
Paclitaxel
IMRT
Fraction
Stage III
4D PET/CT
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
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action