Appendix ZOOM Etude pour site internet Inclusion criteria

Département d’oncologie
Centre de Thérapies Expérimentales
Unité d’Investigation Clinique (UIC)
Doc Nr: UIC-MOP-APP-023
ZOOM Etude pour site Internet
Appendix
ZOOM Etude pour site internet
Indication
Title
Cancer colorectal
Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients.
A randomized, double-blinded, placebo-controlled, phase III trial
Protocol ID
SAKK 41/13
Phase
III
Sponsor
SAKK
Principal
Investigator
Dr. D. Wagner
Primary Objective
The trial objective is to demonstrate a statistically significant and
clinically relevant disease-free survival benefit in stage II and III
PIK3CA mutated colon cancer patients taking daily adjuvant aspirin for
3 years.
Inclusion/exclusion
criteria
Inclusion criteria
1. Written informed consent according to ICH/GCP regulations before
inclusion and prior to any trial-related investigations.
2. Histologically confirmed diagnosis of adenocarcinoma of the colon.
3. Stage II (pT3/T4 N0 cM0) or stage III (pTx pN+ cM0) colon cancer.
4. Availability of cancer tissue for central molecular testing.
5. Presence of predefined, activating PIK3CA mutation in exons 9 or 20
(centrally assessed).
6. Complete resection of the primary tumor (R0) within 10 weeks
maximum before registration.
7. WHO performance status 0-2.
8. Age between 18.80 years.
9. Adequate hematological values: hemoglobin >80 g/L, platelets >50 x
109/L.
10 Calculated creatinine clearance > 30 mL/min, according to the formula
of Cockcroft-Gault.
11 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.
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Département d’oncologie
Centre de Thérapies Expérimentales
Unité d’Investigation Clinique (UIC)
Doc Nr: UIC-MOP-APP-023
ZOOM Etude pour site Internet
Exclusion criteria
1. Previous or concomitant malignancy within 3 years of registration,
except for adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer.
2. Multiple adenocarcinomas of the colon.
3. Rectal cancer (defined as distance from anal verge to proximal/oral
tumor edge ≤15 cm).
4. 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.
5. Systemic rheumatic diseases or degenerative disorders affecting the
musculoskeletal system with a relevant risk of requiring treatment with
NSAIDs in the future.
6. Comorbidities that require regular (i.e. more than 3x per month, any
dose) intake of acetylsalicylic acid or other NSAIDs or COX-2 inhibitors.
7. Clinically relevant upper gastrointestinal bleeding within 12 months prior
to registration.
8. Presence of any bleeding disorder that is an absolute contraindication
to the use of aspirin.
9. 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).
10. 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).
11. Psychiatric disorder precluding understanding of trial information,
giving informed consent or interfering with compliance for oral drug intake.
12. Any familial, sociological or geographical condition potentially
hampering proper staging and compliance with the trial protocol.
13. Known or suspected hypersensitivity to any component of the trial drug
or any agent given in association with this trial.
14. Any concomitant drugs contraindicated for use with the trial drug
according to the approved product information.
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Centre de Thérapies Expérimentales
Unité d’Investigation Clinique (UIC)
Doc Nr: UIC-MOP-APP-023
ZOOM Etude pour site Internet
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