Trial Outcomes & Findings for Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer (NCT NCT02394548)

NCT ID: NCT02394548

Last Updated: 2021-12-09

Results Overview

Esophagitis will be measured using the Common Toxicity Criteria for Adverse Effects (CTCAE) v4 scoring scale

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: up to 3 months
• Results posted on: 2021-12-09

Participant Flow

One participant was consented but never began treatment

Participant milestones

Measure	Contralateral Esophagus Sparing Technique (CEST) IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis
Overall Study STARTED	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer

Baseline characteristics by cohort

Measure	Contralateral Esophagus Sparing Technique (CEST) n=26 Participants IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 months

Esophagitis will be measured using the Common Toxicity Criteria for Adverse Effects (CTCAE) v4 scoring scale

Outcome measures

Measure	Contralateral Esophagus Sparing Technique (CEST) n=26 Participants IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis
Number of Participants With Grade 3 or Higher Acute Esophagitis (CTCAE)	0 Participants

SECONDARY outcome

Timeframe: Baseline , up to 3 Months

Esophagitis will be measured using the historical Radiation Therapy Oncology Group (RTOG) scoring scale

Outcome measures

Measure	Contralateral Esophagus Sparing Technique (CEST) n=26 Participants IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis
Number of Participants With Grade 3 or Higher Acute Esophagitis (RTOG)	0 Participants

SECONDARY outcome

Timeframe: Baseline, up to 2 Years

Adverse events will be measured using CTCAE v4 scoring scale

Outcome measures

Measure	Contralateral Esophagus Sparing Technique (CEST) n=26 Participants IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis
Number of Participants With Adverse Events	24 Participants

SECONDARY outcome

Timeframe: Median follow-up of up to 2 years

Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. No isolated locoregional tumor failures at a median follow-up of up to 2 years.

Outcome measures

Measure	Contralateral Esophagus Sparing Technique (CEST) n=26 Participants IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis
Rate of Local and Regional Failure	0 locoregional tumor failures

SECONDARY outcome

Timeframe: 2 Years

Follow-up time will be calculated from the date of registration to the date of death or the last follow-up date on which the patient was reported alive. Overall survival rates will be estimated using the Kaplan-Meier method.

Outcome measures

Measure	Contralateral Esophagus Sparing Technique (CEST) n=26 Participants IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis
Overall Survival Rate	67 percentage of participants Interval 45.0 to 82.0

Adverse Events

Contralateral Esophagus Sparing Technique (CEST)

Serious events: 21 serious events

Other events: 18 other events

Deaths: 1 deaths

Serious adverse events

Measure	Contralateral Esophagus Sparing Technique (CEST) n=26 participants at risk IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Cardiac disorders Ventricular Tachycardia	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Blood and lymphatic system disorders Hyperglycemia	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Cardiac disorders Heart Failure	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Blood and lymphatic system disorders Lymphocyte count decreased	73.1% 19/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Blood and lymphatic system disorders Anemia	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Blood and lymphatic system disorders Neutrophil count decreased	42.3% 11/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Blood and lymphatic system disorders white blood cell count decreased	30.8% 8/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Blood and lymphatic system disorders Leukocytosis	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.

Other adverse events

Measure	Contralateral Esophagus Sparing Technique (CEST) n=26 participants at risk IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Contralateral Esophageal Sparing Technique (CEST): Determine whether CEST decreases rate of severe acute esophagitis
Respiratory, thoracic and mediastinal disorders Esophagitis	30.8% 8/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
General disorders Fatigue	23.1% 6/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 2/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Skin and subcutaneous tissue disorders Pruritus	7.7% 2/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Skin and subcutaneous tissue disorders Dermatitis Radiation	19.2% 5/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Skin and subcutaneous tissue disorders Erythema	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.4% 4/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Cardiac disorders Atrial Fibrillation	7.7% 2/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Gastrointestinal disorders Gerd	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Gastrointestinal disorders Dysphagia	11.5% 3/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Gastrointestinal disorders Nausea	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Blood and lymphatic system disorders Hyponatremia	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Psychiatric disorders Anxiety	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Gastrointestinal disorders Dyspepsia	11.5% 3/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Gastrointestinal disorders Oral Thrush	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	3.8% 1/26 • From the start of treatment up to 2 years Serious adverse events were defined as adverse events with a grade of 3 or higher that were deemed to be possibly, probably, or definitely related to treatment.

Additional Information

Dr. Henning Willers

Massachusetts General Hospital

Phone: 617-726-5184

Email: hwillers@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place