Trial Outcomes & Findings for Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma (NCT NCT04465162)
NCT ID: NCT04465162
Last Updated: 2022-03-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Through study completion, up to 10 years
Results posted on
2022-03-02
Participant Flow
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.
Participant milestones
| Measure |
Treatment (Radiation Therapy)
Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
Radiation Therapy: Undergo radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
73
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment (Radiation Therapy)
n=73 Participants
Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
Radiation Therapy: Undergo radiation therapy
|
|---|---|
|
Age, Continuous
|
57 years
n=73 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=73 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=73 Participants
|
|
Clinical Stage
I
|
61 Participants
n=73 Participants
|
|
Clinical Stage
II
|
10 Participants
n=73 Participants
|
|
Clinical Stage
IV
|
2 Participants
n=73 Participants
|
|
Tumor Location
Head and neck (nonorbit)
|
13 Participants
n=73 Participants
|
|
Tumor Location
Orbit
|
17 Participants
n=73 Participants
|
|
Tumor Location
Stomach
|
34 Participants
n=73 Participants
|
|
Tumor Location
Skin
|
4 Participants
n=73 Participants
|
|
Tumor Location
Other
|
5 Participants
n=73 Participants
|
|
Helicobacter pylori positive at initial diagnosis
|
13 Participants
n=34 Participants • Participants with gastric Mucosa-Associated Lymphoid Tissue (MALT) and were Helicobacter pylori positive at the time of initial diagnosis.
|
|
Treatment before radiation therapy
Antibiotics
|
22 Participants
n=73 Participants
|
|
Treatment before radiation therapy
Rituximab
|
3 Participants
n=73 Participants
|
|
Treatment before radiation therapy
Surgery
|
19 Participants
n=73 Participants
|
|
Treatment before radiation therapy
Other
|
1 Participants
n=73 Participants
|
|
Treatment before radiation therapy
None
|
27 Participants
n=73 Participants
|
|
Treatment before radiation therapy
Unknown
|
1 Participants
n=73 Participants
|
|
Radiation dose, Gy
24-28.5
|
8 Participants
n=73 Participants
|
|
Radiation dose, Gy
30-30.6
|
45 Participants
n=73 Participants
|
|
Radiation dose, Gy
33-39.6
|
20 Participants
n=73 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 10 yearsRFS 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.
Outcome measures
| Measure |
Treatment (Radiation Therapy)
n=73 Participants
Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
Radiation Therapy: Undergo radiation therapy
|
|---|---|
|
Relapse-free Survival (RFS)
|
83 months
Interval 74.0 to 93.0
|
SECONDARY outcome
Timeframe: 17.5 yearsPFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.
Outcome measures
| Measure |
Treatment (Radiation Therapy)
n=73 Participants
Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
Radiation Therapy: Undergo radiation therapy
|
|---|---|
|
Median Progression Free Survival (PFS)
|
17.5 months
Interval 11.5 to
survival curve for upper limit does not cross 50% survival
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 yearsPFS 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.
Outcome measures
| Measure |
Treatment (Radiation Therapy)
n=73 Participants
Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
Radiation Therapy: Undergo radiation therapy
|
|---|---|
|
Progression Free Survival (PFS) at 10 Years
|
73 months
Interval 60.0 to 84.0
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 yearsOverall 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.
Outcome measures
| Measure |
Treatment (Radiation Therapy)
n=73 Participants
Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
Radiation Therapy: Undergo radiation therapy
|
|---|---|
|
10 Year Overall Survival (OS)
|
86 months
Interval 77.0 to 96.0
|
Adverse Events
Treatment (Radiation Therapy)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Radiation Therapy)
n=73 participants at risk
Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
Radiation Therapy: Undergo radiation therapy
|
|---|---|
|
Gastrointestinal disorders
Fatigue
|
17.8%
13/73 • 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
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
32.9%
24/73 • 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
|
|
Eye disorders
Eye toxicities
|
17.8%
13/73 • 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
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/73 • 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
|
|
Eye disorders
Retinopathy
|
1.4%
1/73 • 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
|
|
Eye disorders
Cataracts
|
8.2%
6/73 • 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
|
|
Eye disorders
Xerostomia
|
9.6%
7/73 • 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
|
|
Ear and labyrinth disorders
Ear
|
1.4%
1/73 • 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
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/73 • 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
|
|
Skin and subcutaneous tissue disorders
Skin
|
32.9%
24/73 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Larynx
|
6.8%
5/73 • 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
|
|
Gastrointestinal disorders
Salivary
|
11.0%
8/73 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
6.8%
5/73 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pharynx
|
16.4%
12/73 • 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
|
|
Gastrointestinal disorders
Upper GI
|
38.4%
28/73 • 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
|
|
Gastrointestinal disorders
Lower GI
|
6.8%
5/73 • 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
|
|
Renal and urinary disorders
Genitourinary
|
1.4%
1/73 • 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
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/73 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Lung
|
1.4%
1/73 • 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
|
|
General disorders
Bone
|
1.4%
1/73 • 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
|
|
Renal and urinary disorders
Bladder
|
1.4%
1/73 • 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
|
Additional Information
Dr. Bouthaina S Dabaja, MD-Professor, Radiation Oncology Department
UT MD Anderson Cancer Center
Phone: (713) 563-2406
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place