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JOURNAL ONKOLOGIE – STUDIE

Evaluating Trifluridine/Tipiracil Based Chemoradiation in Locally Advanced Rectal Cancer - The Phase I/II TARC Trial

Rekrutierend

NCT-Nummer:
NCT04177602

Studienbeginn:
November 2019

Letztes Update:
19.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Rectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Universitätsklinikum Hamburg-Eppendorf

Collaborator:
Clinical Trial Center North (CTC North GmbH & Co. KG), Servier Affaires Médicales,

Studienleiter

Alexander Stein
Principal Investigator
University Cancer Center Hamburg

Kontakt

Studienlocations
(3 von 8)

Malteser Krankenhaus St. Franziskus Hospital
24939 Flensburg
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Nadezda Basara, Prof
Phone: +49 461 816 2512
E-Mail: Nadezda.Basara@malteser.org
» Ansprechpartner anzeigen
Lübecker Onkologische Schwerpunktpraxis Dres. med. Uthgenannt, Kirso, Weber
23562 Luebeck
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jens Kisro, Dr
Phone: +49 451 70797 226
E-Mail: jens.kisro@t-online.de
» Ansprechpartner anzeigen
University Medical Center Halle
Halle/Saale
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Mascha Binder, Prof
E-Mail: mascha.binder@uk-halle.de

Thomas Reese
E-Mail: thomas.reese@uk-halle.de
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Hämatologisch- Onkologische Praxis Eppendorf (HOPE)
20249 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Eray Goekkurt, Dr
Phone: +49 40 36035 220
E-Mail: goekkurt@onkologie-eppendorf.de
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II. Medizinische Klinik und Poliklinik Hubertus Wald Tumorzentrum - UCCH
20251 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Marianne Sinn, Dr
Phone: +49(0)407410
Phone (ext.): 70434
E-Mail: ma.sinn@uke.de

Thomas Mueller
Phone: +49(0)7410
Phone (ext.): 57725
E-Mail: tho.mueller@uke.de
» Ansprechpartner anzeigen
Überörtliche Gemeinschaftspraxis für Innere Medizin Schwerpunkt Hämatologie, Onkologie und Palliativmedizin Dres. Verpoort, Wierecky & Zeller
20259 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jan Wierecky, Dr
Phone: +49 40 3571777 0
E-Mail: wierecky@onkologie-hamburg.de
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Hämatologisch- Onkologische Praxis Altona (HOPA)
22767 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Gunter Schuch, Dr
Phone: +49 40 380212 60
E-Mail: gunter.schuch@hopa-hamburg.de
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Alle anzeigen

Studien-Informationen

Detailed Description:

This is a multicenter randomized seamless phase I/II trial with a phase I for determination

of maximum tolerated dose (MTD) of Trifluridine/tipiracil, followed by a randomized phase II

trial (randomization ratio 2:1) with an experimental arm with Trifluridine/tipiracil in

combination with standard radiotherapy and a standard - calibration arm (internal control)

with capecitabine CRT flanked by translational research, designed to assess the clinical

performance and efficacy of Trifluridine/tipiracil compared to current standard capecitabine

chemoradiation in patients with locally advanced rectal cancer.

The primary clinical objective in phase I is to determine the dosage and feasibility of

Trifluridine/tipiracil based chemoradiation and in phase II whether Trifluridine/tipiracil

with preoperative chemoradiation improves pathological complete remissions in patients with

locally advanced rectal cancer.

The secondary objectives are to evaluate Trifluridine/tipiracil chemoradiation with respect

to disease free survival, overall survival, local regional failure, pathological down-staging

(ypT0-2N0) rate, tumour regression grade, histopathological R0 resection rate, neoadjuvant

rectal score (NAR), and perioperative complication rate. Safety and toxicity, according to

NCI CTC AE v5, quality of life and feasibility of the regimen are further secondary

objectives that are to be evaluated.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Male or female patients with histologically proven adenocarcinoma of the rectum

(tumour ≤ 12 cm from the anal verge)

2. Indication for neoadjuvant chemoradiation: clinical tumour stage T3/4 or any

node-positive disease (clinical stage according the TNM classification system, based

on MRI).

3. No evidence of metastatic disease (as evidenced by negative CT-scan of the chest and

abdomen).

4. The disease must be considered either resectable at the time of entry or expected to

become resectable after preoperative chemoradiation.

5. Age ≥ 18 years

6. WHO/ECOG Performance Status ≤ 2

7. No prior cytotoxic chemotherapy or radiotherapy for rectal cancer.

8. No prior radiotherapy to the pelvis, for any reason.

9. Presence of adequate contraception in fertile patients. Adequate methods of

contraception are: intra-uterine device, hormonal contraception, condom use with

spermicide. Pregnant or breastfeeding women are excluded from participation.

10. Adequate bone marrow, hepatic and renal function: Haemoglobin ≥9.0 g/dL (transfusions

allowed to achieve or maintain levels), absolute neutrophil count ≥ 1.5 x 109/L,

platelet count ≥ 100 x 109/L, ALAT, ASAT ≤ 2.5 x ULN, Alkaline phosphatase ≤ 2.5 x

ULN, Total bilirubin ≤1.5 x ULN, Creatinine clearance > 50 mL/min (calculated

according to Cockroft and Gault).

11. Ability to swallow tablets.

12. Written informed consent and patient's agreement to comply with the study protocol.

Exclusion Criteria:

1. Previous (within the last 3 years) or concurrent malignancies, with the exception of

adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell

carcinoma of the skin.

2. Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure,

symptomatic coronary artery disease and cardiac arrhythmia not well controlled with

medication) or myocardial infarction within the last 12 months.

3. Known allergy or any other adverse reaction to any of the study drugs or to any

related compound.

4. Known significant impairment of intestinal resorption (e.g. chronic diarrhea,

inflammatory bowel disease).

5. Pre-existing condition which would deter chemoradiotherapy or radiotherapy, i.e.

fistulas, severe ulcerative colitis (particularly patients currently taking

sulphasalazine), Crohn's disease, prior adhesions.

Studien-Rationale

Primary outcome:

1. Maximum tolerated dose (MTD)/Phase 1 part (Time Frame - 8 weeks):
Toxicity

2. Rate of pathological complete remissions (pCR)/Phase 2 part (Time Frame - 3 months):
Pathohistological response

Secondary outcome:

1. Disease free survival (DFS) (Time Frame - 4 years):
recurrence and survival

2. Overall survival (OS) (Time Frame - 4 years):
Survival

3. Loco-regional failure (Time Frame - 4 years):
Loco-regional recurrence

4. Histopathological R0 resection rate (Time Frame - 3 months):
Pathohistological response

5. Tumour regression grades (Time Frame - 3 months):
Pathohistological response

6. Pathological down-staging (ypT0-2N0) rate (Time Frame - 3 months):
Pathohistological response

7. Neoadjuvant rectal score (NAR) (Time Frame - 3 months):
Clinical stage and Pathohistological response (<8 low, 8-16 intermediate, >16 high risk)

8. Adverse event rate (Time Frame - 3 months):
Rate of adverse events according to NCI CTC AE v5

9. Rate of perioperative complications (Time Frame - 3 months):
Perioperative complications

Studien-Arme

  • Experimental: Trifluridine/tipiracil based radiotherapy
    Trifluridine/tipiracil based chemoradiotherapy (CRT)
  • Active Comparator: standard calibration arm (internal control)
    capecitabine based chemoradiotherapy

Geprüfte Regime

  • Trifluridine/tipiracil chemoradiation:
    Trifluridine/tipiracil based chemoradiation
  • Capecitabine based chemoradiation:
    Capecitabine based chemoradiation

Quelle: ClinicalTrials.gov


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