Clinical trial NCT03481114: Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
Official title: Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer: A Randomized Trial Comparing Two Radiotherapy Schedules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: radiation therapy
chemotherapy
PET Imaging
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: PRO-CTCAE adverse events with score ≥ 3, observed 6 weeks after initiation of chemoradiotherapy
timeFrame: 6 Weeks after initiation of Chemoradiation
Secondary outcomes:
measure: Locoregional progression-free survival
timeFrame: Weeks 19, 32 and 45 on study
measure: Progression-free survival
timeFrame: Weeks 19, 32 and 45 on study
measure: Overall survival
timeFrame: From treatment start through 5 years post treatment
measure: Grade 3-5 adverse events, scored using CTCAE v. 4
timeFrame: From treatment start through study week 45
measure: PRO-CTCAE adverse events with score ≥ 3 at any time
timeFrame: From treatment start through study week 45
measure: PRO-CTCAE adverse events with any score
timeFrame: From treatment start through study week 45
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Nitin Ohri, MD
role: PRINCIPAL_INVESTIGATOR
References: