Neoplasms

Mouth and Tooth Diseases

All Conditions

Rare Diseases

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Antineoplastic Agents

All Drugs and Chemicals

Everolimus

Exemestane

Letrozole

Nilotinib

Sunitinib

Imatinib Mesylate

Deferasirox

Adults (18 years old or more) with one of the following oral oncology treatments: letrozole, exémestane, imatinib, sunitinib, nilotinib, evérolimus, déférasirox

Bugnon Olivier, Professor

Lüthi François, Dr

Schneider Marie-Paule, PhD

Chevaux Bernard, Dr

Troxler Stéphanie, PhD Student

Leila Achtari, MD

The purpose of this study is to implement a support interdisciplinary program(oncologists, pharmacists, physicians, nurses, leagues against cancer) of medication adherence to oral oncology treatments. The aim is to ensure continuity of care between professionals,effectiveness of treatment and patient safety.

80 patients will be included in swiss-romande hospitals and private oncologists and followed by thirty study pharmacies. Each refusal and drop-out will be documented. Follow-up duration is 48 weeks, with a motivational interviewing at least every three months. Patient adherence will be assessed electronically by MEMS (Medication Event Monitoring System).

Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment

Collaborative and Seamless Care in Oncology : a Study in Primary Care to Measure and Reinforce Safety and Adherence to Oral Cancer Treatment

MEMS data, completed by informations given in motivational interviewing

Evaluating the implementation of the program in pharmacies

By MEMS data and motivational interviewing informations

To evaluate the frequency and severity of ADR and the pharmacist's contribution to their management. Data from motivational interviewing.

Centre Hospitalier Universitaire Vaudois

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Hypoglycemic Agents

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Metformin

Aspirin

Olaparib

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Poly(ADP-ribose) Polymerase Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Acetylsalicylic acid tablets 160 mg x1 orally

Acetylsalicylic acid

Line Bjørge, MD, PhD

The study will be conducted in women with advanced (stage IIIa-IV) ovarian cancer of the histologic subtype high grade serous carcinoma (HGSOC) who are going through a diagnostic laparoscopy. They will recieve treatment with a study agent for 10-14 days before surgery. They will be allocated to different study groups according to the diagnostic evaluation performed as standard of care at the department. The study is randomized and unblinded.

The primary investigational agents are:

1. Metformin tablets, 850 mg x 2 orally.
2. Acetylsalicylic acid tablets, 160 mg x1 orally
3. Olaparib capsules, 300 mg x 2 orally
4. Letrozol tablets, 2.5 mg x 1 orally

The women who agree to participate in the study prior to the laparoscopic evaluation, will be allocated to different study groups according to the diagnostic evaluation performed as standard of care at the department. During inclusion in the first study cohort, the olaparib cohort (n=32), an additional 16 women are randomized as controls and will not receive neither any study drug nor placebo. The study is unblinded. There will not be randomized controls into the other study cohorts, as the control group collected will be utilized as controls for all study agents.

The women in Arm I will be included in the WOO trial, and will be treated with the study agent for 10-14 days prior to tumor reductive surgery, starting the day of laparoscopic surgery (+1 day). The treatment will be discontinued at the time of tumor reductive surgery.

Currently fourmore agents are evaluated as of particular interest, as well as feasible to introduce, in the WOO study set up: metformin, acetylsalicylic acid, olaparib, and letrozol. The first agent listed in the protocol, metformin, will be given to 32 consequtive women, and drug related analyses will thereafter be performed. The next 32 women included in the study will receive the next agent on the list, acetylsalicylic acid, while analyses for the metformin group is ongoing, and after the acetylsalicylic acid study group has been included the next agent on the list is introduced. Should any of the included women be non-eligable to receive one study drug, they will either receive the next agent on the list of the four study drugs, if eligable, or be included as control.

The women in Arm II who agree to participate in the study will not receive the study medication, but standard neoadjuvant chemotherapy until having decreased tumor load radiologically estimated and scheduled for optimal debulking procedure according to standard treatment of this group of patients. Samples from these women will be used as control in the translational part of the where we aim to identify potential molecular pathway(s) and cell type(s) that may be responsible for suboptimal debulking.

During the cancer-directed surgical procedure in participants in both Arms additional tissue samples from matching sites, preferably from tissues removed as part of the operation, as well as blood and urine samples, are obtained for comparative analysis. By use of the collected samples we can evaluate the clinical and molecular impact of the study agents among those triaged to primary cytoreductive surgery. Promising therapeutic targets identified might later be explored separately in one of the consequtive treatment study groups.

After the debulking surgery all women will follow the recommended standard of care, including chemotherapy and consolidating bevacisumab where indicated.

The first treatment cohort has a randomized design 2:1 (olaparib 32:control 16). The study is unblinded. In the following treatment arms are initiated each will included patients (n=32) will be offered the study-prespecified treatment drug.

IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC

IMPACT: A Phase 0 Randomized Window-of-Opportunity Study of Novel and Repurposed Therapeutic Agents in Women Triaged to Primary Surgery for Advanced Epithelial Ovarian Cancer in Stages IIIa - IV.

A characterization of the tumor tissues from each patient will be performed (in pair). For each drug a specific biomarker is selected. The changes in expression of the defined biomarkers represent the primary outcome parameters. biomarkers related to the study agents and operability

Haukeland University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment	NCT01370980	Cancer		18 Years -	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment	NCT01370980	Cancer		18 Years -	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment	NCT01370980	Cancer		18 Years -	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC	NCT03378297	Ovarian Cancer	Metformin Acetylsalicylic... Olaparib Letrozole	18 Years -	Haukeland University Hospital

Spots Global Cancer Trial Database for letrozol

Every month we try and update this database with for letrozol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for letrozol

Every month we try and update this database with for letrozol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for letrozol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.