OV PRECISION: A randomized controlled Swiss study to investigate the benefits of a biology-specific cancer therapy for advanced hard-to-treat ovarian cancer.
Descrizione riassuntiva dello studio
In about one in two patients with ovarian cancer, damage in a repair mechanism is shown to be the cause of its development, which ensures that genetic material is correctly renewed in healthy cells (HRD positive). These patients are more likely to develop ovarian cancer but, on the other hand, respond particularly well to standard chemotherapy with carboplatin. Our study OV PRECISION is specifically intended for the other 50%, the HRD negative patients, of whom we already know that they will not respond as well to standard chemotherapy, thus having a poor prognosis and urgently needing better treatment options. We investigate the applicability of an additional treatment recommendation based on comprehensive biological information and discussion in an expert panel. This recommendation is issued by a specialized so-called molecular tumor board, which is intended to support the treating physician in the clinical practice in treating the patient with advanced ovarian cancer. OV PRECISION combines various biological analyses, evaluates the results as a whole, and can suggest the most effective drugs/experimental therapies for each participating ovarian cancer patient, regardless of the standard treatment. In a randomized study, chance decides whether the participant receives an individual treatment recommendation or not. This eliminates systematic errors and achieves a fair distribution. The experimental group receives the recommendation, discusses it with the physician, and may carry out an individual, recommendation-based treatment for a maximum of 42 days. The control group receives no treatment recommendation and therefore receives standard chemotherapy (42 days). OV PRECISION is being conducted at several Swiss hospitals and is set for 2 years. We expect a total of 60 participants.
(BASEC)
Intervento studiato
Participation in this study lasts 9 weeks and includes, depending on therapy, up to nine study visits including examinations prior to the planned surgery. For routine diagnosis, tumor material is obtained through a biopsy during ultrasound or by draining abdominal fluid or fluid from the lung, which is used, in addition to the normal examination in pathology, for determining the HRD status. To know whether an extensive operation is even reasonable, an initial laparoscopy is performed to assess the extent of the disease. During this operation, tissue samples are taken for analysis. For HRD negative patients, a part of the tumor sample taken here is used for the precise examination of biological properties within the framework of the OV Precision study. HRD positive patients leave the study at this point and receive standard therapy for ovarian cancer, i.e., either the extensive operation or chemotherapy before surgery, depending on the patient's condition and tumor extent. The biology-based individual treatment recommendation by the international expert panel is available to the treating physician and the patient within 2 weeks. An individual, biology-based treatment will be carried out within a time frame of 42 days before the planned surgery. As part of the study visits, a physical examination will be conducted as well as blood count, laboratory values including liver values, electrolytes, kidney values, and the tumor marker CA-125 will be recorded. In addition, participants will be regularly asked about their well-being. This aims to capture the quality of life of the participants and possible side effects of the chosen therapy. The study aims to provide researchers with an indication of a potentially better therapeutic response in HRD negative patients. A better therapeutic response, i.e., a benefit, would manifest in one of the predefined so-called primary (focal) endpoints. This is determined by comparing the number of patients in the experimental arm with those in the control arm at the end of the study regarding their respective treatment responses. For this purpose, tissue examination during the operation is used.
(BASEC)
Malattie studiate
Primary disease of epithelial ovarian cancer, in which no homologous recombination deficiency (no HRD) can be detected.
(BASEC)
- ≥ 18 years and newly diagnosed epithelial ovarian cancer (adenocarcinoma of the ovary, peritoneum, and fallopian tube) or ovarian carcinosarcoma with suspected extensive FIGO stage III and IV -Good general condition (ECOG 0-2) and no immediate need for systemic or surgical treatment at the time of diagnosis and up to 2 weeks thereafter -Planned candidate for surgical reduction/removal of tumor mass after 2 treatment cycles (42 days) (BASEC)
Criteri di esclusione
-Poor general condition (ECOG ≥3) or elevated liver and kidney values - Pregnant and breastfeeding women - Any other malignant tumor disease within the last 5 years that may affect the patient's prognosis. - Simultaneous participation in another clinical study for the same indication - Inability to swallow tablets (BASEC)
Luogo dello studio
Basilea, Berna, Friburgo, San Gallo, Zurigo, Altro
(BASEC)
Baden, Thurgau-Frauenfeld
(BASEC)
Sponsor
Swiss GO Trial Group PD André Fedier Spitalstrasse 21 4031 Basel Schweiz
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Viola Heinzelmann-Schwarz
+41 (0) 61 265 58 83
viola.heinzelmann@clutterusb.chUniversity Hospital Basel
(BASEC)
Informazioni generali
University Hospital Basel, Head Women's Hospital,
+41 61 3284203;+41 (0)61 265 58 83
viola.heinzelmann@clutterusb.ch(ICTRP)
Informazioni generali
University Hospital Basel, Head Women's Hospital
+41 61 3284203
viola.heinzelmann@clutterusb.ch(ICTRP)
Informazioni scientifiche
University Hospital Basel, Head Women's Hospital,
+41 61 3284203;+41 (0)61 265 58 83
viola.heinzelmann@clutterusb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
14.03.2024
(BASEC)
ID di studio ICTRP
NCT06466382 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Tumor-Profiling-based Precision Treatment in Ovarian Cancer, a prospectively randomized controlled Swiss trial (OV Precision). (BASEC)
Titolo accademico
OV PRECISION: A Randomized Controlled Swiss Trial Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy in Ovarian Cancer. (ICTRP)
Titolo pubblico
OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy (ICTRP)
Malattie studiate
Ovarian Neoplasm EpithelialFallopian Tube NeoplasmsOvarian Endometrioid CarcinomaHigh-grade Serous Ovarian Carcinoma (HGSOC) (ICTRP)
Intervento studiato
Other: Treatment recommendation by molecular tumorboard (mTB) based on tumor profilingDrug: Carboplatin / Paclitaxel Chemotherapy (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Newly diagnosed EOC (adenocarcinoma of the ovary, peritoneum, and fallopian tube)
and carcinosarcoma patients with a suspected FIGO Stage III and IV
- No immediate need of systemic or surgical treatment at time of and until 2 weeks
after diagnosis
- Envisaged surgical candidate for interval debulking after 2 cycles of treatment
- Willing and able to attend the visits, to understand the purpose of the trial and
all trial-related procedures
- ECOG 0-2
- Written informed consent according to national legal and regulatory requirements
prior to any project specific procedures
Exclusion Criteria:
- Elevated liver enzymes (double of normal range: ASAT > 68 U/l ALAT > 82 U/l GGT >
80 U/l)
- Elevated creatinine (double of normal range: >120 mmol/l))
- ECOG =3
- Pregnant or lactating women
- Any other malignancy within the last 5 years which has an impact on the prognosis of
the patient
- Inability to swallow tablets
- Concurrent participation in another clinical trial on the same indication
- Any other serious underlying medical, psychiatric, psychological, familial, or
geographical condition, which in the judgment of the sponsor-project leader may
interfere with the project or affect patient compliance (ICTRP)
non disponibile
Endpoint primari e secondari
Focal Outcome Measure (FOM) 1 of pilot study: Proportion of patients for whom the molecular Tumor Board (mTB) considers a different treatment option;FOM 2 of pilot study: Investigation whether the treating oncologist feels better supported by the mTB recommendation considers the additional biological tumor information than by the standard of care where such information is not considered.;FOM 3 of pilot study: Investigation of different treatment decisions by the patient and the treating oncologist.;FOM 4 of pilot study: Preliminary estimate of the actual patient benefit of the intervention in terms of a number of patient-relevant outcomes. (ICTRP)
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Tumor Profiler Center Switzerland (ICTRP)
Contatti aggiuntivi
Viola Heinzelmann-Schwarz, Prof.;Maren S Vogel, PhD;Viola Heinzelmann-Schwarz, Prof, maren.vogel@usb.ch; viola.heinzelmann@usb.ch, +41 61 3284203;+41 (0)61 265 58 83, University Hospital Basel, Head Women's Hospital, (ICTRP)
ID secondari
Swiss-GO-08/ OV Precision (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06466382 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile