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Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer (REPAINT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03481114
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Nitin Ohri, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE August 28, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
PRO-CTCAE adverse events with score ≥ 3, observed 6 weeks after initiation of chemoradiotherapy [ Time Frame: 6 Weeks after initiation of Chemoradiation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • Locoregional progression-free survival [ Time Frame: Weeks 19, 32 and 45 on study ]
    Lack of local disease progression based on repeat imaging
  • Progression-free survival [ Time Frame: Weeks 19, 32 and 45 on study ]
    Lack of any disease progression based on repeat imaging
  • Overall survival [ Time Frame: From treatment start through 5 years post treatment ]
    Follow ups will be maintained with study patients to determine survival status
  • Grade 3-5 adverse events, scored using CTCAE v. 4 [ Time Frame: From treatment start through study week 45 ]
    Evaluation of any side effects or toxicities using a standard grading system
  • PRO-CTCAE adverse events with score ≥ 3 at any time [ Time Frame: From treatment start through study week 45 ]
    Evaluation of severe, patient reported side effects or toxicities
  • PRO-CTCAE adverse events with any score [ Time Frame: From treatment start through study week 45 ]
    Evaluation of any patient reported side effects or toxicities
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 Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
Official Title  ICMJE Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer: A Randomized Trial Comparing Two Radiotherapy Schedules
Brief Summary The primary objective of this study is to evaluate patient-reported outcomes during and after concurrent chemoradiotherapy for locally-advanced non-small cell lung cancer. Patients will be randomized to a standard 6-week radiotherapy course or a 4-week radiotherapy course using dose-painting based on pre-treatment PET findings.
Detailed Description

This study is open for patients with non-small cell lung cancer. This study offers such patients the chance for a shorter and more personalized treatment course utilizing PET imaging.

Patients will be stratified based on performance status and tumor size and randomized to one of two treatment plans:

  1. PET-based, dose-painted, accelerated chemoradiotherapy over 4 weeks (20 radiotherapy fractions)
  2. Standard chemoradiotherapy over 6 weeks (30 radiotherapy fractions)

All patients will receive standard weekly doses of chemotherapy (carboplatin and paclitaxel) during radiotherapy. This may be followed by adjuvant systemic therapy, at the discretion of the treating physicians.

All patients will undergo standard evaluations prior to enrollment, during treatment, and after treatment. Additionally, patient-reported outcomes will be assessed periodically using a PRO-CTCAE tool.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Combination Product: PET-based, dose-painted, accelerated chemoradiotherapy
    Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
  • Combination Product: Standard chemoradiotherapy
    Patients in this arm will receive a standard radiotherapy course.
Study Arms  ICMJE
  • Active Comparator: Standard chemoradiotherapy
    Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
    Intervention: Combination Product: Standard chemoradiotherapy
  • Experimental: PET-based, dose-painted, accelerated chemoradiotherapy,
    For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
    Intervention: Combination Product: PET-based, dose-painted, accelerated chemoradiotherapy
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages (according to the AJCC Staging Manual, 7th edition,

Appendix):

  • Stage IIIA or IIIB
  • Stage II NSCLC with contraindication to curative surgical resection
  • Stage IV disease with solitary brain metastasis that has been treated radically (eg: with surgical resection and/or stereotactic radiosurgery) and thoracic disease that would be classified as stage II-III

Appropriate diagnostic/staging workup, including:

  • Complete history and physical examination
  • PET/CT within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s). If PET/CT was obtained more than 42 days prior to study entry and is not repeated, chest CT within 28 days prior to study entry demonstrating stable disease is required.
  • MRI of the brain or head CT with contrast within 42 days prior to study entry
  • No prior chemotherapy or thoracic radiotherapy for lung cancer
  • ECOG Performance Status 0-2
  • Age > 18
  • Able to read and write in one of the following languages, in which the PROCTCAE tool is available: English, Danish, German, Italian, Japanese, Korean, Spanish
  • Laboratory studies obtained within 28 days prior to study entry demonstrating adequate bone marrow and end organ function
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy, agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed,and be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy.

All patients must sign study specific informed consent prior to study entry.

Exclusion Criteria:

  • Pleural or pericardial effusion (A patient with pleural effusion may be enrolled the effusion is sampled by thoracentesis and cytology is negative or the effusion is seen on axial imaging but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance.)
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
  • Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study therapy
  • have a positive pregnancy test at baseline
  • are pregnant or breastfeeding
  • Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications. Patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians
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: Sarah Yukelis 718-920-5636 sarah.yukelis@einsteinmed.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03481114
Other Study ID Numbers  ICMJE 2017-8065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nitin Ohri, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nitin Ohri, MD Montefiore Medical Center
PRS Account Albert Einstein College of Medicine
Verification Date April 2020

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