Trial Outcomes & Findings for Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma (NCT NCT01186978)

Last Updated: 2020-06-02

Results Overview

This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the number of participants with local control at 5 years, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

5 years

Results posted on

2020-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Overall Study STARTED	63
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=63 Participants This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 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	6 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Single Arm n=62 Participants This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Number of Participants With Local Control	61 Participants

SECONDARY outcome

Timeframe: 5 years

Progression-free survival (PFS) will be defined as the time from on-study to disease progression or death due to any cause, whichever comes first.

Outcome measures

Outcome measures
Measure	Single Arm n=62 Participants This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Percentage of Participants With Progression-free Survival at 5 Years	83 percentage of participants Interval 67.0 to 93.0

SECONDARY outcome

Timeframe: 5 years

Overall survival will be defined as the number of participants who are alive

Outcome measures

Outcome measures
Measure	Single Arm n=62 Participants This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Percentage of Participants With Overall Survival	90 percentage of participants Interval 73.0 to 98.0

SECONDARY outcome

Timeframe: 5 years

To examine the patterns of failure, we will tabulate the various ways that patients failed up until the time of the analysis. For example, these ways will include local only, local + distant, and distant only.

Outcome measures

Outcome measures
Measure	Single Arm n=62 Participants This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Number of Participants With Local, Distant, or Local+Distant Failure Local failure	1 Participants
Number of Participants With Local, Distant, or Local+Distant Failure Distant failure	6 Participants
Number of Participants With Local, Distant, or Local+Distant Failure Local+distant failure	0 Participants

Adverse Events

Single Arm

Serious events: 4 serious events

Other events: 16 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=63 participants at risk This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Endocrine disorders Papillary thyroid cancer	1.6% 1/63 • 5 years
Skin and subcutaneous tissue disorders Squamous cell carcinoma	3.2% 2/63 • 5 years
Renal and urinary disorders Papillary carcinoma of the kidney	1.6% 1/63 • 5 years

Other adverse events

Other adverse events
Measure	Single Arm n=63 participants at risk This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity. Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Ear and labyrinth disorders Ear fullness	1.6% 1/63 • 5 years
Gastrointestinal disorders Dental caries	1.6% 1/63 • 5 years
Gastrointestinal disorders Dysphagia	6.3% 4/63 • 5 years
Gastrointestinal disorders Odynophagia	3.2% 2/63 • 5 years
General disorders Dysgeusia	1.6% 1/63 • 5 years
Gastrointestinal disorders Gastroesophageal reflux	1.6% 1/63 • 5 years
Gastrointestinal disorders Oral mucositis	1.6% 1/63 • 5 years
Gastrointestinal disorders Nausea	15.9% 10/63 • 5 years
Respiratory, thoracic and mediastinal disorders Non-cardiac chest pain	11.1% 7/63 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.6% 1/63 • 5 years
Respiratory, thoracic and mediastinal disorders Post-nasal drip	1.6% 1/63 • 5 years
Blood and lymphatic system disorders Neutropenia	3.2% 2/63 • 5 years
Blood and lymphatic system disorders Leukopenia	1.6% 1/63 • 5 years
Cardiac disorders Idiopathic cardiomyopathy	1.6% 1/63 • 5 years
Cardiac disorders Depressed ejection fraction	1.6% 1/63 • 5 years
Gastrointestinal disorders Vomiting	3.2% 2/63 • 5 years

Additional Information

Assistant Research Practice Manager (ARPM) for Clinical Trials

Duke University Health System

Phone: 919-668-5211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place