Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Follicular lymphoma (grade 1 or 2 or 3A)

Marginal zone lymphoma (nodal or extranodal)

Follicle center lymphoma

Disqualifiers

Pregnant women

Nursing women

Women of childbearing potential who are unwilling to employ adequate contraception

T-cell lymphoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Endoscopic Procedure

    Procedure/Surgery

    Undergo endoscopy

  • Involved-site Radiation Therapy (3 Fractions)

    Radiation

    Undergo ISRT in 3 fractions

  • Involved-site Radiation Therapy (12 Fractions)

    Radiation

    Undergo ISRT in 12 fractions

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: ARM 1 (reduced dose ISRT)Experimental treatment 5 interventions
Group B: ARM 2 (SOC ISRT)Active comparator 5 interventions

Trial outcomes

Primary outcomes

1

Incidence of grade 2 or higher acute adverse events (AEs)

AEs will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Acute toxicity will be reported as a proportion calculated as the number of patients with acute toxicity divided by the total number of treatment patients. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).

Time frame
Up to 14 days after radiation treatment

Secondary outcomes

1

Response rate

Response rate will be defined as the proportion of patients displaying response (complete response or partial response) at 3 months post treatment. Complete response is defined as the disappearance of all signs of cancer in response to treatment. Partial response is defined decrease in the size of target lesions by ≥ 50%, with no increase in the size of any lesion and no appearance of new lesions. Treated patients who do not have a 3-month evaluation will be classified as a non-response. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).

Time frame
Up to 3 months after radiation treatment
2

Time to progression rate

Local control will be defined as the number of days from end of radiation treatment until first local recurrence within 24 months post radiation treatment. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).

Time frame
Up to 24 months after radiation treatment
3

Patient reported quality of life

Patient reported quality of life will be measured using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, a 13-item questionnaire answered on a scale of 1-5 where 1=Not at all and 5=Very much. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).

Time frame
Up to 3 months after radiation treatment

Other outcomes

Sponsors and contacts

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