DLBCL: Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01186978
• Collaborator: (none)
• Enrollment: 63
• Locations: 3
• Arm: 1
• Actual Duration (Months): 104.4
• Patients Per Site: 21
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity.

Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-cell Lymphoma	Radiation: Radiation Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
• Actual Study Start Date: Sep 20, 2010
• Actual Primary Completion Date: Jun 4, 2019
• Actual Study Completion Date: Jun 4, 2019

Arms and Interventions

Arm

Intervention/Treatment

Other: 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: Radiation Therapy; 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Local Control [5 years]

   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.

Secondary Outcome Measures

1. Percentage of Participants With Progression-free Survival at 5 Years [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.

2. Percentage of Participants With Overall Survival [5 years]

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

3. Number of Participants With Local, Distant, or Local+Distant Failure [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification

• Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy

• Negative post-chemotherapy (or interim) PET scan

• Absolute neutrophil count greater than 1500 and platelet count greater than 40,000

• Negative pregnancy test in women of child-bearing potential

For patients with HIV/AIDS, the following must be true:

• The patient is compliant on combination anti-retroviral therapy (CART)

• The patient has CD4 count ≥ 200 at time of diagnosis

Exclusion Criteria:

• Any contraindications to irradiation

• Primary CNS lymphoma

• HIV/AIDS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham Regional Hospital	Durham	North Carolina	United States	27704
2	Duke University Medical Center	Durham	North Carolina	United States	27710
3	Duke Raleigh Hospital	Raleigh	North Carolina	United States	27609

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Christopher Kelsey, MD, Duke University Medical Center, Radiation Oncology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 11, 2015

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01186978
• Other Study ID Numbers: Pro00025164
• First Posted: Aug 23, 2010
• Last Update Posted: Jun 2, 2020
• Last Verified: May 1, 2020

• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Study Results

Participant Flow

Arm/Group Title	Single Arm
Arm/Group Description	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
Period Title: Overall Study
STARTED	63
COMPLETED	62
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Single Arm
Arm/Group Description	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 Participants	63
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	58
Sex: Female, Male (Count of Participants)
Female	34 54%
Male	29 46%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.2%
Not Hispanic or Latino	61 96.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 6.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 9.5%
White	52 82.5%
More than one race	1 1.6%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	63 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Local Control
Description	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.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm
Arm/Group Description	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
Measure Participants	62
Count of Participants [Participants]	61 96.8%

2. Secondary Outcome

Title	Percentage of Participants With Progression-free Survival at 5 Years
Description	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.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm
Arm/Group Description	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
Measure Participants	62
Number (95% Confidence Interval) [percentage of participants]	83 131.7%

3. Secondary Outcome

Title	Percentage of Participants With Overall Survival
Description	Overall survival will be defined as the number of participants who are alive
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm
Arm/Group Description	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
Measure Participants	62
Number (95% Confidence Interval) [percentage of participants]	90 142.9%

4. Secondary Outcome

Title	Number of Participants With Local, Distant, or Local+Distant Failure
Description	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.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm
Arm/Group Description	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
Measure Participants	62
Local failure	1 1.6%
Distant failure	6 9.5%
Local+distant failure	0 0%

Adverse Events

Time Frame	5 years
Arm/Group Title	Single Arm
Arm/Group Description	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
All Cause Mortality
	Single Arm
	Affected / at Risk (%)	# Events
Total	3/63 (4.8%)
Serious Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	4/63 (6.3%)
Endocrine disorders
Papillary thyroid cancer	1/63 (1.6%)
Renal and urinary disorders
Papillary carcinoma of the kidney	1/63 (1.6%)
Skin and subcutaneous tissue disorders
Squamous cell carcinoma	2/63 (3.2%)
Other (Not Including Serious) Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	16/63 (25.4%)
Blood and lymphatic system disorders
Neutropenia	2/63 (3.2%)
Leukopenia	1/63 (1.6%)
Cardiac disorders
Idiopathic cardiomyopathy	1/63 (1.6%)
Depressed ejection fraction	1/63 (1.6%)
Ear and labyrinth disorders
Ear fullness	1/63 (1.6%)
Gastrointestinal disorders
Dental caries	1/63 (1.6%)
Dysphagia	4/63 (6.3%)
Odynophagia	2/63 (3.2%)
Gastroesophageal reflux	1/63 (1.6%)
Oral mucositis	1/63 (1.6%)
Nausea	10/63 (15.9%)
Vomiting	2/63 (3.2%)
General disorders
Dysgeusia	1/63 (1.6%)
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain	7/63 (11.1%)
Pneumonitis	1/63 (1.6%)
Post-nasal drip	1/63 (1.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.