NCT04465162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2000

Completed
19.9 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

20.8 years

First QC Date

May 6, 2020

Results QC Date

January 5, 2022

Last Update Submit

February 25, 2022

Conditions

Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueExtranodal Marginal Zone LymphomaAnn Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Median Progression Free Survival (PFS)

    17.5 years

  • Progression Free Survival (PFS) at 10 Years

    Through study completion, up to 10 years

  • 10 Year Overall Survival (OS)

    Through study completion, up to 10 years

Study Arms (1)

Treatment (radiation therapy)

EXPERIMENTAL

Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.

Other: Radiation Therapy

Interventions

Radiation TherapyOTHER

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Treatment (radiation therapy)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 33309978DERIVED

Related Links

MeSH Terms

Interventions

RadiotherapyRadiation

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Phenomena

Results Point of Contact

Title
Dr. Bouthaina S Dabaja, MD-Professor, Radiation Oncology Department
Organization
UT MD Anderson Cancer Center
bdabaja@mdanderson.org
(713) 563-2406

Study Officials

  • Bouthaina S Dabaja

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

July 9, 2020

Study Start

June 7, 2000

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

March 2, 2022

Results First Posted

March 2, 2022

Record last verified: 2022-02

Locations

US(1)