MDACC Study Summary ID99-384

Study Summary
No. ID99-384:.......Lymphoma......Bouthaina Dabaja......Radiation Oncology

Study Summary Title



Study Summary Number:	ID99-384

Study Title:	Radiation Therapy alone for stage 1 and 2 MALT (mucosa-associated lymphoid tissue) lymphoma

Physician

New Patient Referral



Name:	Bouthaina Dabaja	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Follow-up between 6 weeks to two months, and then every 3-4 months for the first year, every 4-6 months for the second year, every 6 months for the third & fourth year, and once a year thereafter or as per physician's discretion.

Treatment Agents:	Radiation	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	06/07/2000

IRB Review and Approval Date:	12/15/1999

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

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

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

3) Patients who failed other treatment modalities (e.g. chemo, antibiotics therapy) may have never had stage 3 or 4 disease during the course of the disease or disease progression to the opposite side of diaphragm. (As the time course of response to antibiotic therapy can be very variable, sometimes requiring more than 1 year for complete response, failure to antibiotic therapy can be very variable among patients, sometimes requiring more than 1 year for complete response, failure to antibiotic treatment will be defined as no response or progression of disease documented by endoscopy & biopsy)

4) 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:

1) 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.

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

3) 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.

4) 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.

Links

Registration Number: Not Applicable Clinical Trial