Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases
Randomised Controlled Phase I/II Trail to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation Therapy in Resectable Colorectal Liver Metastases Patients
The efficiency of T cell based immunotherapies is affected by the insufficient migration and activity of tumor specific effector T cells in the tumor. Aim of this phase I/II clinical trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve T cell connected anti tumor immune response in colorectal liver metastases.
The primary endpoint is the number of tumor infiltrating T cells. Furthermore the T cell activity in situ, the number of regulatory T cells and the frequency of tumor reactive T cells in the blood and bone marrow will be examined.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Heidelberg, Tyskland, 69120
- Rekruttering
- University of Heidelberg
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Ta kontakt med:
- Juergen Weitz
- Telefonnummer: +49 6221 56 6250
- E-post: juergen.weitz@med.uni-heidelberg.de
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Ta kontakt med:
- Christoph Reissfelder
- Telefonnummer: +49 6221 56 6250
- E-post: christoph.reissfelder@med.uni-heidelberg.de
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
- Age ≥ 50 years
- Radiological urgently suspected colorectal liver metastasis
Exclusion Criteria:
- second malignancy
- Pregnancy and lactation
- no prior liver radiation
- liver metastasis must be resectable
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Radiation 0,5Gy
Radiation: one time Radiation with an intensity of 0.5 Gy Group A Beginning on a weekday 48 hours before surgery |
Radiation: one time Radiation with an intensity of 0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery |
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Aktiv komparator: No radiation
Control group with 0Gy radiation
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Control group with 0Gy
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Aktiv komparator: Radiation 2Gy
Radiation: one time Radiation with an intensity of 2.0 Gy Group B Beginning on a weekday 48 hours before surgery |
Radiation: one time Radiation with an intensity of 0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery |
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Aktiv komparator: Radiation 5Gy
Radiation: one time Radiation with an intensity of 5 Gy Group C Beginning on a weekday 48 hours before surgery |
Radiation: one time Radiation with an intensity of 0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumor activity
Tidsramme: 2 years
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2 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To determine local control and recurrence patterns of colorectal liver metastases in a CT
Tidsramme: 2 years
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2 years
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To determine the progression-free survival in patients treated with low dose photon beam radiation therapy
Tidsramme: 2 years
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2 years
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• To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment
Tidsramme: 2 years
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2 years
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• To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment
Tidsramme: 2 years
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2 years
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• To determine the T-cell activity in the resected liver tissue
Tidsramme: 2 years
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2 years
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• To determine quality of life according to the EORTC QoL questionnaire after 6 months.
Tidsramme: 6 months
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6 months
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To determine the number of regulatory T-cells in the resected liver tissue
Tidsramme: 2 years
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2 years
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To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients
Tidsramme: 2 years
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2 years
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To determine quality of life according to the EORTC QoL questionnaire after 12 months.
Tidsramme: 1 year
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1 year
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To determine the number of patients with adverse events as a measure of safety and tolerability according to CTCAE, Version 4.0 criteria
Tidsramme: 2 years
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2 years
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- S081/2008
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