Beschreibung

Phase II Trial to assess the Efficacy of Low Radiation Dose of 20 Gy for the Treatment of Marginal Zone Lymphoma or Follicular Lymphoma Stage I-II localized in the Stomach or the Duodenum

Studientherapie

Involved Site RadioTherapy (ISRT) with 20 Gy

Studienstatus

Rekrutierung gestartet/nimmt Patienten auf

Allgemeine Infos zum Antrag

Frau Dr. med. Gabriele Reinartz
gabriele.reinartz@ukmuenster.de

Universitätsklinikum Münster - Münster (Institution, 12051)
Klinik für Strahlentherapie - Radioonkologie
Albert-Schweitzer-Campus 1
48149 Münster

The primary objective is to demonstrate the efficacy and safety of the low-dose RT concept with 20 Gy (10x2 Gy). Therefore, the overall response rate (ORR) to radiation treatment is examined to evaluate whether the interventional administration of 20 Gy is not relevantly inferior to international standard dose of 30 Gy.

The secondary objectives are the recording and analysis of the following criteria: quality of life and survival rates (event-free survival, lymphoma specific survival, progression-free survival, overall survival). During and after radiation treatment the acute and chronic adverse effects, including possible Adverse Events (AEs) and Serious Adverse Events (SAEs) will be collected.
Certain inflammatory cytokines are known to be elevated in patients with low-grade gastrointestinal lymphoma. In addition, cytokine profiles after radiation exposure are dose dependent. The effects of the radiation dose regimen on the production of cytokines (IL-1ß, IL-4, IL-8, TNFalpha) and other inflammation relevant molecules (Syndecan1, MMP-2 and S100 proteins) are to be investigated. Determination of the relationship between radiation exposure, inflammatory response and (complete) remission rate of each gastrointestinal lymphoma subtype is intended in order to optimize and personalize radiation therapy treatment for each patient.

Primary indolent (MZL or FL) gastric or duodenal lymphoma St. I or II

Primary endpoint analysis: The primary endpoint is the overall response rate (ORR) 6 months after end of treatment. It will be analysed by a one-sample non-inferiority binomial test. The one-sided significance level is 2.5%, the power is 80%. It will be tested whether ORR will be non-inferior to 0.95, with non-inferiority margin (difference) 0.1, i.e. it will be tested whether the lower limit of the one-sided 97.5% confidence interval by Clopper-Pearson will be greater than 0.85. Secondary endpoint analysis: The pre-specified secondary endpoints will be analysed with appropriate statistical methods depending on the type of variable, e.g. rates are analysed by binomial test and exact 95%-confidence interval, time-to-event endpoints by one-sample log-rank test.

Response rate 6 months after end of treatment, 4 categories according to GELA-criteria: CR (complete remission) = CR or pMRD (probable minimal residual disease), PR (partial remission) = rRD (responding residual disease), NC (no change), PD (progressive disease)

QoL according to EORTC (QLQ C30 and STO22). EFS=Event-free survival (time to any failure or death from any cause, patients in CR or PR), LSS=lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients), PFS=Progression-free survival (time to progression of lymphoma or death from any cause, all patients), OS=overall survival (time to death from any cause, all patients). Level of cytokines IL-1², IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins. Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA.
Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)
-Assessment of safety: Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Spezifische Infos zum Antrag

Ja

• Synopsis_ILROG Study Protocol_ISRT 20Gy Indolent Lymphoma Stomach and Duodenum_V01_14.05.2