Fallopian Tube Neoplasms Clinical Trial
— OVPrecisionOfficial title:
OV PRECISION: A Randomized Controlled Swiss Trial Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy in Ovarian Cancer.
The long-term goal of this research project is to demonstrate whether HRD negative (HPR) patients benefit when additional multimodal biological tumor information is incorporated into the molecular tumor board (mTB) treatment recommendation process.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 2027 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Newly diagnosed EOC 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) - Elevated creatinine (double of normal range ) - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitätsspital Basel | Basel | Basel Stadt |
Lead Sponsor | Collaborator |
---|---|
Swiss GO Trial Group | Tumor Profiler Center Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Focal Outcome Measure (FOM) 1 of pilot study: Proportion of patients for whom the molecular Tumor Board (mTB) considers a different treatment option | Number (proportion) of cases in which the Tumor Profiling (TP) was able to generate a conclusive Molecular Summary Report (MSR)
Number (proportion) of cases in which the mTB considers the MSR as useful support for making a treatment recommendation on a scale from zero (not useful at all) to five (very useful) |
2-3 weeks | |
Primary | 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. | Number (proportion) of cases in which the treating physician considers the mTB recommendation as useful for making a final treatment decision on a scale from zero (not useful at all) to five (very useful).
Definition of molecular results from TP that cannot be used for clinical decision making. Definition of an algorithm for the decision process from MSR to treatment recommendation. |
2-3 weeks | |
Primary | FOM 3 of pilot study: Investigation of different treatment decisions by the patient and the treating oncologist. | Number of therapy adaptations in the exploratory arm based on the MSR.
Number (proportion) of cases with therapy adaptions with minor / major/ no change from SOC. Number (proportion) of treatment recommendations by mTB which were followed by the doctor and patient in the window of opportunity. Number (proportion) of treatment recommendations by mTB which were continued by the doctor and patient after the trial and after finishing SOC. Number (proportion) of treatment recommendations by mTB which were not followed by the doctor and patient in the window of opportunity due to restrictions. Differences in hypothetical treatment costs between SOC and exploratory arm. |
4 weeks | |
Primary | FOM 4 of pilot study: Preliminary estimate of the actual patient benefit of the intervention in terms of a number of patient-relevant outcomes. | The difference in proportions of responders between the standard of care and experimental arm after interval debulking surgery or biopsy at second specimen collection time point (week 10). A patient is classified as a responder if at least one of the two conditions is met: The Chemotherapy Response Score (CRS) is larger than or equal to 2 or the CA125 KELIM score is larger than or equal to 1.
Note A : The three-tired CRS ranges from 1 (no or minimal tumor response) to 3 (total or near-total tumor response) . Note B: The tumormarker CA125 level decline (= CA125 KELIM ) over at least 3 timepoints can give an indication of therapy response. A favourable KELIM score = 1.0,Unfavorable KELIM score < 1. Symptoms measured by MOST- S26 questionnaire from V1 (baseline at diagnosis) until V9 (EOT), in both arms. Qualitiy of Life (QoL): Questionnaires EORTC QLQ-C30, EORTC QLQ-OV28 from V1 (baseline at diagnosis) until V9 (EOT), in both arms. |
10 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03648489 -
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)
|
Phase 2 | |
Completed |
NCT00415181 -
Pharmacogenomics of Paclitaxel in Ovarian Cancer
|
N/A | |
Completed |
NCT00063401 -
Phase II Study in Patients With Epidermal Growth Factor Receptor (EGFR) + Advanced Stage Ovarian, Primary Peritoneal and Fallopian Tube Cancer
|
Phase 2 | |
Completed |
NCT00035100 -
EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
|
Phase 2 | |
Withdrawn |
NCT01228942 -
A Prospective Trial of COXEN Chemotherapy Prediction
|
N/A | |
Completed |
NCT00074867 -
Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer
|
Phase 2 | |
Completed |
NCT00191646 -
An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
|
Phase 3 | |
Recruiting |
NCT05960630 -
MIRRORS-RCT Pilot: Role of Robotic Interval Cytoreductive Surgery for Advanced Ovarian Cancer
|
N/A | |
Completed |
NCT01846611 -
A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 3 | |
Recruiting |
NCT04556071 -
Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer
|
Phase 2 | |
Recruiting |
NCT04111978 -
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
|
Phase 3 | |
Withdrawn |
NCT01766622 -
18F-CP18 Imaging Studies for Cancer Treatment With Birinapant
|
Phase 2 | |
Recruiting |
NCT05617755 -
AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer
|
Phase 1 | |
Completed |
NCT01478685 -
A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors
|
Phase 1 | |
Completed |
NCT02903771 -
Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.
|
Phase 1 | |
Completed |
NCT01462890 -
Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer
|
Phase 3 | |
Completed |
NCT00391118 -
Comparing Two Treatments for Ovarian Cancer: Standard Chemotherapy Plus Enzastaurin, or Placebo ("Sugar Pill")
|
Phase 2 | |
Terminated |
NCT00407407 -
ABI-007 With Carboplatin as First-Line Therapy in Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
|
Phase 1 | |
Completed |
NCT00189345 -
Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients
|
Phase 2 | |
Completed |
NCT00443196 -
Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas
|
Phase 2/Phase 3 |