Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Peritoneal Neoplasms

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

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Huaier granule is supplied as 20-g granule. Huaier granule will be administered as 20 g orally tid x 28 days (continuous). One cycle = 28 days. There is no planned treatment interruption between cycles. In the absence of intolerable toxicity, a patient may continue to receive treatment with Huaier granule until disease progression, or until 24 months have elapsed.

Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity.

Huaier granule

This study is an exploratory, single-center, prospective single-arm study to explore the efficacy of Huaier granules in the treatment of stage Ⅱ-Ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (R0/R1). Twenty-five patients with FIGOⅡ-Ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with Huaier granules. During the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity. This is an exploratory, single-center, prospective single-arm study to explore the efficacy of Huaier granules in the treatment of stage Ⅱ-Ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (R0/R1). Twenty-five patients with FIGOⅡ-Ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with Huaier granules. During the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity.

Primary Objective:

To evaluate the efficacy of Huai er granule in the treatment of stage I primary ovarian cancer, fallopian tube cancer and peritoneal cancer

Secondary objectives:

1. To analyze the safety of Huaier granule in the treatment of ovarian fallopian tube cancer and peritoneal cancer after operation;
2. To analyze the influence of Huaier granule on the quality of life of postoperative patients with ovarian fallopian tube cancer and peritoneal cancer

Exploratory objective:

To evaluate the efficacy of Huaier granule in patients with BRCA mutation and BRCA wild-type ovarian cancer

Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer

Efficacy and Safety of Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer: a Single-center Prospective Single-arm Study

The time from study entry to the time of disease progression as determined by the investigator (by clinical, radiological or pathological means) or death from any cause

PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.

Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol.

The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section

In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.

frequency of adverse events according to MedDRA terms

Ruijin Hospital

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Vaccines

Poly ICLC

Monatide (IMS 3015)

Interferons

Immunologic Factors

Adjuvants, Immunologic

Subjects in ARM 1 will receive the vaccination with OC-L alone

subjects in ARM 2 will receive vaccination with OC-L admixed with Montanide,

subjects in ARM3 will receive vaccination with OC-L admixed with 1 mg poly-ICLC (Hiltonol)

subjects in ARM 4 will receive vaccination with OC-L admixed with both Montanide and 1 mg poly-ICLC.

OC-L

Montanide

poly-ICLC (Hiltonol),

This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate vaccine (OC-L) administered with GMCSF in subjects with primary epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Autologous OC-L Vaccine and Ovarian Cancer

A Randomized Pilot Trial to Test the Addition of Montanide and Polyiclc to Autologous Oxidized Tumor Cell Lysate Vaccine in Combination With Gmcsf in Primary Advanced Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Ovarian Cancer Research Center

Abramson Cancer Center at Penn Medicine

Carcinoma, Endometrioid

Adenocarcinoma

Endometrial Neoplasms

Uterine Neoplasms

Letrozole

Estrogens

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Letrozole, 2.5 mg Femara tablet, administered once daily for 5 years or until symptoms of toxicity or progression of underlying disease

Placebo tablet of Femara (without aromatase inhibitor), 0 mg Femara tablet, administered once daily for 5 years or progression of underlying disease

Letrozole 2.5mg

Placebo

Pamela McLaughlin, PhD

Maren Vogel, PhD

Ursula Sevelda, Dr. med.

Edgar Petru, Prof. Dr.

Christian Marth, Prof. Dr.

Cornelia Peternell, Dr med.

Barbara Spreitzer

Judith Lafleur, Dr. med.

Gerhard Bogner, PD. Dr. med.

Stephan Polterauer, Assoc. Prof. Priv. Doz. Dr.

Ursula Denison, Dr. med.

Petra Hnizdo

Radoslav Chekerov, PD Dr med

Klaus Pietzner, PD Dr med

Sara Tato-Varela, Dr. med.

Walter Kuhn, Prof.Dr.med.

Carolin Nestle-Krämling, Dr med

Eleni Tsepelidou, Dr med

Julia Welz, Dr. med.

Philipp Harter, Prof Dr med.

Alexander Hein, PD Dr med

Bettina Braun, Dr med

Maximillian Klar, Prof Dr med

Florin-Andrei Taran, Prof Dr med

Christoph Uleer, Dr med

Jasmin Pourfard, Dr med

Andreas Zorr, Dr med

Kristina Bätge, MD

Daniel Rein, Prof Dr med

Christin Traut, MD

Ralph Witteler, Dr med

Sebastian Schäfer, Dr med

Martina Gropp-Meier, Dr. med.

Thomas Decker, Prof Dr med.

Michael Weigel, Prof

Elke Wiegand, Dr. med.

Michael Eichbaum, Prof Dr med

Tatjana Cordes, Dr med

clemens Liebrich, Dr med

Vanessa Zahn, MD

Viola Heinzelmann-Schwarz, Prof

Dimitri Sarlos, PD

Maria Del Grande, Dr med,

Martin Heubner, Prof.

Thomas Schmid, Dr. med.

Julian Wampfler, Dr. med et phil

Ralf Rothmund, Prof.

Michael Schwitter, Dr. med.

Mathias Fehr, Prof.

Intidar Labidi-Galy, Dr. med.

Seraina Schmid, PD

Apostolos Sarivalasis, Dr. med.

Marcus Vetter, Dr. med.

Stefan Aebi, Prof.

Andreas Günthert, Prof

Christian Taverna, Dr. med.

René Hornung, Prof.

Andreas Müller, Dr. med.

Anita Hirschi-Blickenstorfer, Dr. med.

Natalie Gabriel, Dr. med.

Andreas Wicki, Porf.

Viola Heinzelmann-Schwarz, Prof. MD PhD

The purpose of this study is to evaluate the efficacy of addition of letrozole to the standard maintenance therapy in subjects following a primary diagnosis of Estrogen-receptor (ER) positive high and low grade epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) and subsequent primary treatment surgery and chemotherapy. Half of the participants will receive to the standard maintenance treatment, letrozole, whilst the other half receives placebo.

The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).

Femara (letrozole) is an extensively investigated, marketed aromatase inhibitor (AI) widely used as treatment in the maintenance phase of estrogen-receptor (ER) positive breast cancer, as it inhibit the synthesis of estrogens. Estrogen is a well known driver of cancer growth in ER-positive tumors and a high percentage of the epithelial ovarian cancers express ER as well. Of which low grade ovarian cancers demonstrates the highest level of expression, supporting our strategy of a sub-group analysis (LOGOS). Therefore, letrozole in this study be investigated prospectively and evaluated as maintenance therapy after standard surgical and chemotherapy treatment in comparison to placebo (which is the current standard maintenance treatment) in subjects with primary, ER-positive low or high grade serous or endometrioid epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) of FIGO Stage II-IV, whose cancer has not progressed by the end of the platinum-based chemotherapy.

The objectives are to evaluate the letrozole maintenance treatment compared to placebo in terms of

* progression-free survival (PFS; primary endpoint)
* overall survival (OS)
* quality-adjusted progression free survival (QAPFS)
* time to first subsequent treatment (TFST)
* quality-adjusted time without symptoms of toxicity (Q-TWiST)
* health related quality of life (QoL) assessed by EQ-5D-5L, FACT-ES and FACT-O questionnaires

Methods: 540 for this study eligible subjects are 1:1 allocated in this randomized, controlled, double-blinded, multi-centre study to either the test (letrozole) or control (placebo) group. The maximum maintenance treatment duration is 5 years or until symptoms of toxicity or progression of underlying disease.

Health and health-related quality of life will continuously be assessed at study entry and during routine recalls which are scheduled every 12 weeks for the first 2 years, followed by every 24 weeks for the next 3 years. Procedures performed to assess the participants' health are the same as are performed during the regular routine ovarian cancer follow-up visits: blood tests, physical as well as gynaecological examinations and may include imaging. In addition, the participants are asked to complete during the study quality of life (QoL) specific questionnaires and wear an activity tracker for one week just before the scheduled visits. These assessments will be used for the evaluation of letrozole's efficacy and burden in comparison to the standard maintenance treatment. Survival follow-up data after the mainentance treatment duration of 5 years (study end) are obtained for up to another 7 years.

MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)

MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer: a Randomized Double-blinded Placebo-controlled Multi-centre Phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO), Including LOGOS (Low Grade Ovarian Cancer Sub-study).

PFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression.

Assessment of progression (recurrence) is generally indicated by SYMPTOMS and will be assessed by the investigator most commonly on the basis of CT scans of the pelvis, abdomen and thorax, according to RECIST v1.1 criteria recommended and mostly presented by an elevated CA-125 level. Elevated CA-125 levels alone shouldn't be considered as progression. Progression assessment according to local standard of care, however, is similarly acceptable.

OS defined for each patient as the time from the date of first IMP administration until the date of death from any cause. Patients not having an event at the time of analysis will be censored at the date they were last known to be alive.

QAPFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression under consideration of the quality of life during this period. QAPFS incorporates progression-free survival (quantity) and quality of life during this period into a measure of net clinical benefit:

QAPFS = PFS (years or months) x QoL (utility value).

Utility values derived from the EQ-5D-L5 questionnaire will be used.

TFST defined for each patient as the time from the date of first IMP administration until the date the patient started the next (second-line) subsequent anticancer treatment. Patients not receiving a subsequent anticancer treatment at the time of analysis will be censored at the date they were last known to be alive.

Q-TWiST defined as the Quality adjusted Time Without appearance of any Symptoms of Toxicity related to either the progression of the cancer or side effects of the trial medication from the date of first IMP administration until dead.

The Q-TWiST analysis considers the following three health states:

* (1) the period experiencing toxicity (TOX)
* (2) the period before progression without experiencing toxicity (TWiST)
* (3) the period after relapse (REL)

These periods are assigned preference utilities (u), which will be derived using the generic EQ-5D-5L questionnaire.

The Q-TWiST will be calculated as the weighted sum of the time spent in each health state:

Q-TWiST = uTox\*TOX + TWiST + uRel\*REL where u denotes the assigned utility for each respective health state.

Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) is included into the study to more specifically assess the side effects from the IMPs on quality of life. The minimum value is 0, the maximum value for the specific 19 item Endocrine Symptom Subscale (ESS-19) is 76. The higher the score, the better the QOL

In the context of this study the specific ovarian cancer symptom-oriented questionnaire Functional Assessment of Cancer Therapy - Ovarian (FACT-O) is included to assess the progression/recurrence of ovarian cancer on Quality of Life. The minimum value is 0, the maximum value including the specific Ovarian Cancer Subscale (OCS) is 152. The higher the score, the better the QOL

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer	NCT05792254	Primary Ovarian... Fallopian Tube ... Peritoneal Canc...	Huaier granule	18 Years -	Ruijin Hospital
Autologous OC-L Vaccine and Ovarian Cancer	NCT02452775	Primary Ovarian... Fallopian Tube ... Primary Periton...	OC-L Montanide poly-ICLC (Hilt...	18 Years -	Abramson Cancer Center at Penn Medicine
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)	NCT04111978	Ovarian Neoplas... Fallopian Tube ... Peritoneal Neop... High-grade Sero... Low-grade Serou... Ovarian Endomet...	Letrozole 2.5mg Placebo	18 Years -	Swiss GO Trial Group
Autologous OC-L Vaccine and Ovarian Cancer	NCT02452775	Primary Ovarian... Fallopian Tube ... Primary Periton...	OC-L Montanide poly-ICLC (Hilt...	18 Years -	Abramson Cancer Center at Penn Medicine
Autologous OC-L Vaccine and Ovarian Cancer	NCT02452775	Primary Ovarian... Fallopian Tube ... Primary Periton...	OC-L Montanide poly-ICLC (Hilt...	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for primary ovarian cancer