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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local Control | 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression-free Survival at 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. | 5 years |
| Percentage of Participants With Overall Survival |
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Inclusion Criteria:
For patients with HIV/AIDS, the following must be true:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Kelsey, MD | Duke University Medical Center, Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham Regional Hospital | Durham | North Carolina | 27704 | United States | ||
| Duke University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Local Control | 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. | Posted | Count of Participants | Participants | 5 years |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Papillary thyroid cancer | Endocrine disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear fullness | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Research Practice Manager (ARPM) for Clinical Trials | Duke University Health System | 919-668-5211 | Jennifer.Mewshaw@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2015 | Apr 30, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Overall survival will be defined as the number of participants who are alive |
| 5 years |
| Number of Participants With Local, Distant, or Local+Distant Failure | 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. | 5 years |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Duke Raleigh Hospital | Raleigh | North Carolina | 27609 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Progression-free Survival at 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years |
|
|
|
| Secondary | Percentage of Participants With Overall Survival | Overall survival will be defined as the number of participants who are alive | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years |
|
|
|
| Secondary | Number of Participants With Local, Distant, or Local+Distant Failure | 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. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 3 |
| 63 |
| 4 |
| 63 |
| 16 |
| 63 |
| Squamous cell carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Papillary carcinoma of the kidney | Renal and urinary disorders | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysgeusia | General disorders | Non-systematic Assessment |
|
| Gastroesophageal reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oral mucositis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-cardiac chest pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Post-nasal drip | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Idiopathic cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
|
| Depressed ejection fraction | Cardiac disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|