Im Studienportal SNCTP (Swiss National Clinical Trials Portal) werden klinische Versuche in der Schweiz veröffentlicht. Die Daten stammen aus zwei Quellen: Aus der kantonsübergreifenden Gesuchseinreichungsplattform BASEC und der internationalen Studiendatenbank ICTRP (WHO- Datenbank, welche die 17 weltweiten Primärregister umfasst). Aus ICTRP werden nur Studien angezeigt, die in der Schweiz durchgeführt werden – optional lassen sich auch Studien anzeigen, deren Durchführungsort in einem Nachbarland der Schweiz liegt.
SNCTP000001339 | NCT02467582
SAKK 41/13-Aspirin. Ergänzende Aspirin-Behandlung bei Dickdarmkrebs. Eine randomisierte, doppelblinde, Placebo-kontrollierte Phase III Studie.
Datenbasis: BASEC
(Import vom 30.10.2020), WHO (Import vom 25.10.2020) Geändert: 18.10.2020 Krankheitskategorie: Anderer Krebs
Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)
Die Studie untersucht bei Patienten mit operiertem Dickdarmkrebs und vorhandener PIK3CA-Mutation den Einfluss von Aspirin auf die Wahrscheinlichkeit eines Rückfalls der Tumorerkrankung. Etwa 17% der Patienten mit Dickdarmkrebs weisen eine solche Genmutation im Tumorgewebe auf. Das PIK3CA spielt eine wichtige Rolle beim Wachstum und Überleben der Krebszellen. Aspirin enthält den Wirkstoff Acetylsalicylsäure, welcher den Einfluss von PIK3CA auf die Krebszellen möglicherweise verändern kann. Um diesen Einfluss zu untersuchen, wird Aspirin gegenüber Placebo verglichen.
Aspirin 100 mg oder Placebo werden täglich während 3 Jahren verabreicht
Interventions(Datenquelle: WHO)
Drug: Aspirin;Drug: Placebo
Kriterien zur Teilnahme an der Studie
(Datenquelle: BASEC)
- Histologisch bewiesenes Kolonkarzinom.
- Stadium II (pT3/T4 N0 cM0) oder Stadium III (pTx pN+ cM0).
- Aktivierende PIK3CA Mutation in den Exon 9 oder 20.
Ausschlusskriterien
(Datenquelle: BASEC)
- Patienten mit Rektumkarzinom.
- Schwere und unkontrollierte kardiovaskuläre Erkrankung.
Inclusion/Exclusion Criteria(Datenquelle: WHO)
Inclusion Criteria:
- Written informed consent according to ICH/GCP regulations before inclusion and prior to any trial-related investigations.
- Histologically confirmed diagnosis of adenocarcinoma of the colon.
- Stage II (pT3/T4 N0 cM0) or stage III (pTx pN+ cM0) colon cancer.
- Availability of cancer tissue for central molecular testing.
- Presence of predefined, activating PIK3CA mutation in exons 9 or 20 (centrally assessed).
- Complete resection of the primary tumor (R0) within 14 weeks maximum before registration.
- Adequate hepatic function: total bilirubin =1.5xULN, AST =2.5xULN, ALT =2.5xULN, AP =2.5xULN.
- Calculated creatinine clearance > 30 mL/min, according to the formula of Cockcroft-Gault.
- Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential.
Exclusion Criteria:
- Previous or concomitant malignancy within 3 years of registration, except for adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
- Multiple adenocarcinomas of the colon.
- Rectal cancer (defined as distance from anal verge to proximal/oral tumor edge =15 cm).
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction) within three months prior to registration.
- Systemic rheumatic diseases or degenerative disorders affecting the musculoskeletal system with a relevant risk of requiring treatment with NSAIDs in the future.
- Comorbidities that require regular (i.e. more than 3x per month, any dose) intake of acetylsalicylic acid or other NSAIDs or COX-2 inhibitors.
- Clinically relevant upper gastro-intestinal bleeding within 12 months prior to registration.
- Presence of any bleeding disorder that is an absolute contraindication to the use of aspirin.
- General tendency to hypersensitivity and history of asthma triggered by salicylates or substances with a similar mechanism of action, and non-steroidal anti-inflammatory drugs in particular
- Any serious underlying medical condition, at the judgment of the investigator, which could impair the ability of the patient to participate in the trial (e.g. uncontrolled infection, active autoimmune disease, uncontrolled diabetes).
- Concurrent treatment with other experimental drugs or treatment in an interventional clinical trial within 30 days prior to trial entry. Concomitant use of adjuvant chemotherapy for stage III and high risk stage II colon cancer according to international treatment guidelines is allowed (chemotherapy regimens include intravenous 5-fluorouracil or oral capecitabine either alone or in combination with intravenous oxaliplatin).
- Psychiatric disorder precluding understanding of trial information, giving informed consent or interfering with compliance for oral drug intake.
- Any familial, sociological or geographical condition potentially hampering proper staging and compliance with the trial protocol.
- Known or suspected hypersensitivity to any component of the trial drug or any agent given in association with this trial.
- Known galactose-1-phosphate uridyl transferase deficiency, UDP galactose 4 epimerase deficiency, galactokinase deficiency, orFanconi-Bickel syndrome, congenital lactase deficiency,or glucose-galactose malabsorption (due to the lactose-containing placebo).
- Any concomitant drugs contraindicated for use with the trial drug according to the approved product information.
