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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-02549 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ID99-384 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies the side effects of radiation therapy used alone, and if it can achieve a high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors. This treatment may improve the patient's lymphoma.
PRIMARY OBJECTIVE:
I. To determine the efficacy and toxicity of radiation therapy alone in treating stage 1 and 2 MALT lymphoma for newly diagnosed patients and for the patients who failed other treatment modalities.
OUTLINE:
Patients undergo radiation therapy once daily (QD) 5 times weekly over 3.5-5 weeks.
After completion of study treatment, patients are followed up at 6-8 weeks, and then every 3-4 months for year 1, every 4-6 months for year 2, every 6 months for years 3 and 4, and once yearly thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (radiation therapy) | Experimental | Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Other | Undergo radiation therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival (RFS) | RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions. | Through study completion, up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival (PFS) | PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions. | 17.5 years |
| Progression Free Survival (PFS) at 10 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bouthaina S Dabaja | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33309978 | Derived | Fang P, Gunther JR, Pinnix CC, Dong W, Strati P, Nastoupil LJ, Steiner RE, Ahmed S, Damron EP, Fowler N, Nair R, Westin JR, Neelapu S, Ha CS, Dabaja BS. A Prospective Trial of Radiation Therapy Efficacy and Toxicity for Localized Mucosa-associated Lymphoid Tissue (MALT) Lymphoma. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1414-1420. doi: 10.1016/j.ijrobp.2020.11.070. Epub 2020 Dec 10. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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75 participants enrolled in study, 2 participants did not receive Radiation Therapy(RT); 1 owing to discovered stage III disease and 1 who chose observation after complete surgical resection of disease in a gastric polyp.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Radiation Therapy) | Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 11, 2019 |
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PFS events is the time in months and defined as any lymphoma relapse ( lymphoma that comes back after successful treatment and a period of remission) or death from any cause. Kaplan-Meier curves were estimated for the survival distributions.
| Through study completion, up to 10 years |
| 10 Year Overall Survival (OS) | Overall Survival is the time in months from start of study treatment to date of death due to any cause. Overall survival rates are estimated by the Kaplan-Meier method. | Through study completion, up to 10 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Radiation Therapy) | Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Clinical Stage | Stage I. This stage is usually a cancer that has not grown deeply into nearby tissues. It also has not spread to the lymph nodes or other parts of the body. It is often called early-stage cancer. Stage II and Stage III. In general, these 2 stages are cancers that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not to other parts of the body. Stage IV. This stage means that the cancer has spread to other organs or parts of the body. It may be also called advanced or metastatic cancer. | Count of Participants | Participants |
| |||||||||||||||||
| Tumor Location | Count of Participants | Participants |
| ||||||||||||||||||
| Helicobacter pylori positive at initial diagnosis | Participants with gastric Mucosa-Associated Lymphoid Tissue (MALT) and were Helicobacter pylori positive at the time of initial diagnosis. | Count of Participants | Participants |
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| Treatment before radiation therapy | Count of Participants | Participants |
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| Radiation dose, Gy | Count of Participants | Participants |
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| 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 | Relapse-free Survival (RFS) | RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions. | Posted | Median | 95% Confidence Interval | months | Through study completion, up to 10 years |
|
|
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| Secondary | Median Progression Free Survival (PFS) | PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions. | Posted | Median | 95% Confidence Interval | months | 17.5 years |
|
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| Secondary | Progression Free Survival (PFS) at 10 Years | PFS events is the time in months and defined as any lymphoma relapse ( lymphoma that comes back after successful treatment and a period of remission) or death from any cause. Kaplan-Meier curves were estimated for the survival distributions. | Posted | Median | 95% Confidence Interval | months | Through study completion, up to 10 years |
|
| |||||||||||||||||||||||||||
| Secondary | 10 Year Overall Survival (OS) | Overall Survival is the time in months from start of study treatment to date of death due to any cause. Overall survival rates are estimated by the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | Through study completion, up to 10 years |
|
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From the first dose through 30 days after the last dose of study medication, All-Cause Mortality was assessed up to 10 years, and Serious and Other (Not Including Serious) adverse events were assessed up to 9 weeks
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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 | Treatment (Radiation Therapy) | Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy | 11 | 73 | 0 | 73 | 28 | 73 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Gastrointestinal disorders | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Eye toxicities | Eye disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Retinopathy | Eye disorders | Systematic Assessment |
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| Cataracts | Eye disorders | Systematic Assessment |
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| Xerostomia | Eye disorders | Systematic Assessment |
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| Ear | Ear and labyrinth disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Larynx | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Salivary | Gastrointestinal disorders | Systematic Assessment |
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| Mucositis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pharynx | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Upper GI | Gastrointestinal disorders | Systematic Assessment |
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| Lower GI | Gastrointestinal disorders | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Lung | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bone | General disorders | Systematic Assessment |
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| Bladder | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bouthaina S Dabaja, MD-Professor, Radiation Oncology Department | UT MD Anderson Cancer Center | (713) 563-2406 | bdabaja@mdanderson.org |
| Jan 5, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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| II |
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| IV |
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| Stomach |
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| Skin |
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| Other |
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| Surgery |
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| Other |
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| None |
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| Unknown |
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| 33-39.6 |
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