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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

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Combination Product: PET-based, dose-painted, accelerated chemoradiotherapy Combination Product: Standard chemoradiotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer: A Randomized Trial Comparing Two Radiotherapy Schedules
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Combination Product: Standard chemoradiotherapy
Patients in this arm will receive a standard radiotherapy course.

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.
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.




Primary Outcome Measures :
  1. PRO-CTCAE adverse events with score ≥ 3, observed 6 weeks after initiation of chemoradiotherapy [ Time Frame: 6 Weeks after initiation of Chemoradiation ]

Secondary Outcome Measures :
  1. Locoregional progression-free survival [ Time Frame: Weeks 19, 32 and 45 on study ]
    Lack of local disease progression based on repeat imaging

  2. Progression-free survival [ Time Frame: Weeks 19, 32 and 45 on study ]
    Lack of any disease progression based on repeat imaging

  3. Overall survival [ Time Frame: From treatment start through 5 years post treatment ]
    Follow ups will be maintained with study patients to determine survival status

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 (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

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): NCT03481114


Contacts
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Contact: Sarah Yukelis 718-920-5636 sarah.yukelis@einsteinmed.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Sarah Yukelis    718-920-7750    sarah.yukelis@einsteinmed.org   
Principal Investigator: Nitin Ohri, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Nitin Ohri, MD Montefiore Medical Center
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Responsible Party: Nitin Ohri, Associate Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03481114    
Other Study ID Numbers: 2017-8065
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Nitin Ohri, Albert Einstein College of Medicine:
radiation therapy
chemotherapy
PET Imaging
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