Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04465162
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 75
• Location: 1
• Arm: 1
• Actual Duration (Months): 249.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Extranodal Marginal Zone Lymphoma	Other: Radiation Therapy	Phase 2

Detailed Description

PRIMARY OBJECTIVE:

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Radiation Therapy Alone for Stage 1 and 2 MALT (Mucosa-Associated Lymphoid Tissue) Lymphoma
• Actual Study Start Date: Jun 7, 2000
• Actual Primary Completion Date: Mar 15, 2021
• Actual Study Completion Date: Mar 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (radiation therapy) Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.	Other: Radiation Therapy; Undergo radiation therapy; Other Names: Cancer Radiotherapy Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation

Outcome Measures

Primary Outcome Measures

1. Relapse-free Survival (RFS) [Through study completion, up to 10 years]

   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.

Secondary Outcome Measures

1. Median Progression Free Survival (PFS) [17.5 years]

   PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.

2. Progression Free Survival (PFS) at 10 Years [Through study completion, up to 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.

3. 10 Year Overall Survival (OS) [Through study completion, up to 10 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with newly diagnosed stage 1 and 2 MALT lymphoma are eligible for this study

• Patients with Helicobacter (H.) pylori positive gastric MALT lymphoma are recommended to have treatments with antibiotics prior to enrollment to this protocol

• Patients who failed other treatment modalities (e.g. chemotherapy, antibiotics therapy etc) are also eligible as far as they never had stage 3 or 4 disease during the course of the disease or disease progression to the opposite side of the diaphragm (as the time course of the response to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic treatment will be defined as no response or progression of the disease documented by endoscopy and biopsy)

• Patients who have had stage 4 diseases due to bilateral parotid gland or ocular/ocular adnexal involvement or due to multiple sites within Waldeyer's ring will still be eligible

Exclusion Criteria:

• Patients who had previous radiation dose to the site of the current primary disease which would lead to violation of known radiation tolerance limit of that particular site if treated again

• Patients with MALT lymphoma of the skin whose lesions are separated by more than 5 cm will be ineligible

• Previous or concurrent malignancy in any form would not be an exclusion criterion. However, patients who receive chemotherapy for concurrent malignancy will be excluded from statistical analysis

• Low blood cell counts would not be exclusion criteria as far as the patient is willing to accept supportive measures such as transfusions, filgrastim and epoetin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Bouthaina S Dabaja, M.D. Anderson Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 11, 2019

More Information

Additional Information:

• MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT04465162
• Other Study ID Numbers: ID99-384; NCI-2020-02549; ID99-384
• First Posted: Jul 9, 2020
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy
Period Title: Overall Study
STARTED	73
COMPLETED	73
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy
Overall Participants	73
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	57
Sex: Female, Male (Count of Participants)
Female	38 52.1%
Male	35 47.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	73 100%
Clinical Stage (Count of Participants)
I	61 83.6%
II	10 13.7%
IV	2 2.7%
Tumor Location (Count of Participants)
Head and neck (nonorbit)	13 17.8%
Orbit	17 23.3%
Stomach	34 46.6%
Skin	4 5.5%
Other	5 6.8%
Helicobacter pylori positive at initial diagnosis (Count of Participants)
Count of Participants [Participants]	13 17.8%
Treatment before radiation therapy (Count of Participants)
Antibiotics	22 30.1%
Rituximab	3 4.1%
Surgery	19 26%
Other	1 1.4%
None	27 37%
Unknown	1 1.4%
Radiation dose, Gy (Count of Participants)
24-28.5	8 11%
30-30.6	45 61.6%
33-39.6	20 27.4%

Outcome Measures

1. Primary Outcome

Title	Relapse-free Survival (RFS)
Description	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.
Time Frame	Through study completion, up to 10 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy
Measure Participants	73
Median (95% Confidence Interval) [months]	83

2. Secondary Outcome

Title	Median Progression Free Survival (PFS)
Description	PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.
Time Frame	17.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy
Measure Participants	73
Median (95% Confidence Interval) [months]	17.5

3. Secondary Outcome

Title	Progression Free Survival (PFS) at 10 Years
Description	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.
Time Frame	Through study completion, up to 10 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy
Measure Participants	73
Median (95% Confidence Interval) [months]	73

4. Secondary Outcome

Title	10 Year Overall Survival (OS)
Description	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.
Time Frame	Through study completion, up to 10 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy
Measure Participants	73
Median (95% Confidence Interval) [months]	86

Adverse Events

Time Frame	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
Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Radiation Therapy: Undergo radiation therapy
All Cause Mortality
	Treatment (Radiation Therapy)
	Affected / at Risk (%)	# Events
Total	11/73 (15.1%)
Serious Adverse Events
	Treatment (Radiation Therapy)
	Affected / at Risk (%)	# Events
Total	0/73 (0%)
Other (Not Including Serious) Adverse Events
	Treatment (Radiation Therapy)
	Affected / at Risk (%)	# Events
Total	28/73 (38.4%)
Ear and labyrinth disorders
Ear	1/73 (1.4%)
Eye disorders
Eye toxicities	13/73 (17.8%)
Retinopathy	1/73 (1.4%)
Cataracts	6/73 (8.2%)
Xerostomia	7/73 (9.6%)
Gastrointestinal disorders
Fatigue	13/73 (17.8%)
Salivary	8/73 (11%)
Upper GI	28/73 (38.4%)
Lower GI	5/73 (6.8%)
General disorders
Bone	1/73 (1.4%)
Metabolism and nutrition disorders
Dehydration	1/73 (1.4%)
Renal and urinary disorders
Genitourinary	1/73 (1.4%)
Bladder	1/73 (1.4%)
Respiratory, thoracic and mediastinal disorders
Larynx	5/73 (6.8%)
Mucositis	5/73 (6.8%)
Pharynx	12/73 (16.4%)
Lung	1/73 (1.4%)
Skin and subcutaneous tissue disorders
Dermatitis	24/73 (32.9%)
Erythema	1/73 (1.4%)
Alopecia	1/73 (1.4%)
Skin	24/73 (32.9%)

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.