Verlaagde dosis radiotherapie voor de behandeling van indolent non-hodgkinlymfoom
Gehypofractioneerde radiotherapie met verlaagde dosis (3Gy x 3 fracties) voor indolent non-hodgkinlymfoom (POSEIDON): een gerandomiseerde fase 2-studie op meerdere locaties
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
PRIMARY OBJECTIVE:
I. To show that the experimental arm [9 gray (Gy) in 3 fractions, 8 Gy in 2 fractions, or 10 Gy in 5 fractions] has significantly reduced acute toxicity (grade ≥ 2 adverse events at least possibly related to radiation treatment within 14 days after the end of radiation treatment [according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0] compared to 24 Gy in 12 fractions.
SECONDARY OBJECTIVES:
I. To evaluate patient reported quality of life. II. To evaluate response rate. III. To evaluate local control rate. IV. To evaluate relapse-free survival.
EXPLORATORY OBJECTIVES:
I. Financial toxicity will be assessed at the end of radiation treatment. II. Financial health care expenditure will be assessed at the end of radiation treatment III. Late toxicity.
CORRELATIVE RESEARCH OBJECTIVES:
I. Biopsies of enrolled patients will be evaluated for pathological assessment of cellular and genetic mutations to correlate them with disease local relapse and radiation resistance.
II. Patients will have their baseline positron emission tomography (PET)/computed tomography (CT) scan undergo auto-segmentation to calculate the functional imaging 18-fluoro-deoxyglucose (FDG) metabolic tumor volume (MTV), total lesions glycolysis (TLG) and maximum standardized uptake volume (SUVmax) of the sites to be treated with involved-site radiation therapy (ISRT) using MIMvista platform to correlate it with disease local relapse and treatment response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo reduced dose ISRT once daily (QD) over 3, 2, or 5 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
ARM II: Patients undergo standard of care (SOC) radiation therapy QD over 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
After completion of study treatment, patients are followed up at days 7 and 14, months 3 and 6, and then every 6 months for up to 2 years post-radiation therapy.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Clinical Trials Referral Office
- Telefoonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
Studie Locaties
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Arizona
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Scottsdale, Arizona, Verenigde Staten, 85259
- Werving
- Mayo Clinic in Arizona
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Contact:
- Clinical Trials Referral Office
- Telefoonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
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Hoofdonderzoeker:
- William G. Rule, MD
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224-9980
- Werving
- Mayo Clinic in Florida
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Contact:
- Clinical Trials Referral Office
- Telefoonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
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Hoofdonderzoeker:
- Brad S. Hoppe, MD, MPH
-
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Minnesota
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Albert Lea, Minnesota, Verenigde Staten, 56007
- Werving
- Mayo Clinic Health System in Albert Lea
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Contact:
- Clinical Trials Referral Office
- Telefoonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
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Hoofdonderzoeker:
- John Yeakel, MD
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Mankato, Minnesota, Verenigde Staten, 56001
- Ingetrokken
- Mayo Clinic Health System - Mankato
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Rochester, Minnesota, Verenigde Staten, 55905
- Werving
- Mayo Clinic in Rochester
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Contact:
- Clinical Trials Referral Office
- Telefoonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
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Hoofdonderzoeker:
- Scott C. Lester, MD
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Wisconsin
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Eau Claire, Wisconsin, Verenigde Staten, 54701
- Werving
- Mayo Clinic Health System-Eau Claire Clinic
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Contact:
- Clinical Trials Referral Office
- Telefoonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
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Hoofdonderzoeker:
- Now Bahar Alam, MD
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La Crosse, Wisconsin, Verenigde Staten, 54601
- Werving
- Mayo Clinic Health System-Franciscan Healthcare
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Contact:
- Clinical Trials Referral Office
- Telefoonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
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Hoofdonderzoeker:
- Abigail L. Stockham, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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Age ≥ 18 years
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Histological confirmation of indolent B-cell lymphoma that can include any of the following:
- Follicular lymphoma (grade 1 or 2 or 3A)
- Marginal zone lymphoma (nodal or extranodal)
- Follicle center lymphoma
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Any stage disease
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Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3
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Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
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Provide written informed consent
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Ability to complete questionnaire(s) by themselves or with assistance
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Willing to return to enrolling institution for follow-up visits (during the active monitoring phase of the study). Virtual visits can also be considered as an option for applicable items
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Confirmation from radiation oncologist of suitability to participate in study
Exclusion Criteria:
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Any of the following:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
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T-cell lymphoma
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Receiving treatment for small and chronic lymphocytic lymphoma
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Grade 3B follicular lymphoma
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: ARM 1 (reduced dose ISRT)
Patients undergo reduced dose ISRT once daily (excluding weekends): 9 Gy delivered in 3 treatment fractions or 8 Gy in 2 fractions. At physician discretion, patients may receive 10 Gy in 5 fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up. |
Ancillary studies Undergo CT or PET/CT
Andere namen:
Undergo PET/CT
Andere namen:
Undergo endoscopy
Andere namen:
Undergo ISRT in 3 fractions
Andere namen:
|
|
Actieve vergelijker: ARM 2 (SOC ISRT)
Patients undergo standard of care (SOC) radiation therapy once daily (excluding weekends): 24 Gy in 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up. |
Ancillary studies Undergo CT or PET/CT
Andere namen:
Undergo PET/CT
Andere namen:
Undergo endoscopy
Andere namen:
Undergo ISRT in 12 fractions
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of grade 2 or higher acute adverse events (AEs)
Tijdsspanne: Up to 14 days after radiation treatment
|
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). |
Up to 14 days after radiation treatment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Response rate
Tijdsspanne: Up to 3 months after radiation treatment
|
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). |
Up to 3 months after radiation treatment
|
|
Time to progression rate
Tijdsspanne: Up to 24 months after radiation treatment
|
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). |
Up to 24 months after radiation treatment
|
|
Patient reported quality of life
Tijdsspanne: Up to 3 months after radiation treatment
|
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). |
Up to 3 months after radiation treatment
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Brad S. Hoppe, MD, MPH, Mayo Clinic
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MC230808
- 23-010273 (Andere identificatie: Mayo Clinic Institutional Review Board)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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