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

Carcinoma

Fallopian Tube Neoplasms

Peritoneal Neoplasms

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

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

* Paclitaxel (175mg/m2) and carboplatin (AUC 5.0 or 6.0) IV, D1, every three weeks.
* Two cycles of neoadjuvant chemotherapy and four cycles of adjuvant chemotherapy.

* Paclitaxel (175mg/m2) and carboplatin (AUC 5.0 or 6.0) IV, D1, every three weeks.
* Three cycles of neoadjuvant chemotherapy and three cycles of adjuvant chemotherapy.

Two and three cycles of neoadjuvant chemotherapy will be administered in experimental and control groups, respectively

Two cycles of neoadjuvant chemotherapy

Hee Seung Kim, MD/PhD

Soo Jin Park, MD

Moon Kyoung Bae

Te hypothesized that two cycles of neoadjuvant chemotherapy followed by interval debulking surgery would improve survival in advanced epithelial ovarian, fallopian, and primary peritoneal cancer because reduction of one cycle of chemotherapy can lead to the removal of more tumor burden, compared with three cycles of neoadjuvant chemotherapy.

So the investigators aim to compare survival, rate of successful optimal cytoreductive surgery, post-operative complications, and quality of life between two and three cycles of neoadjuvant chemotherapy followed by interval debulking surgery for advanced epithelial ovarian, fallopian, and primary peritoneal cancer.

Primary debulking surgery (PDS) followed by adjuvant chemotherapy is the standard treatment for advanced epithelial ovarian, fallopian and primary peritoneal cancer. However, three or four cycles of neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS) has been introduced in clinical setting because four randomized controlled trials related have shown a lower rate of complications in NAC followed by IDS despite the similar efficacy between PDS and NAC followed by IDS in advanced epithelial ovarian, fallopian and primary peritoneal cancers. However, these trials have some limitations that the rate of optimal cytoreduction defined as the size of residual tumor \<1 cm was about 40%, which was a disappointed result not showing the surgical effect improving survival. Nevertheless, more treatment strategies using NAC followed by IDS should be investigated because NAC followed by IDS has been already known as another standard treatment due to the safety.

A recent meta-analysis has reported that reduction of one cycle of neoadjuvant chemotherapy may increase overall survival of 4.1 months because it can induce surgical resection of more visible tumors with drug-resistant. Moreover, a related clinical trial has shown that hyperthermic intraperitoneal chemotherapy (HIPEC) may increase survival in patients with advanced ovarian cancer who received three cycles of neoadjuvant chemotherapy because HIPEC can kill drug-resistant invisible tumor cells which were not resected during IDS. Thus, the investigators designed a phase 3, multicenter, randomized controlled trial for comparing survival, clinical outcomes and quality of life between two and three cycles of NAC followed by IDS, and thereby will investigate the efficacy and safety of reduction of one cycle of NAC.

Comparison of clinical outcomes between two and three cycles of neoadjuvant chemotherapy followed by interval debulking surgery.

Reduction Of Cycles of neOadjuvant Chemotherapy for Advanced Epithelial Ovarian, Fallopian and Primary Peritoneal Cancer

Multi-center, Randomized Controlled, Phase III Trials to Evaluate the Safety and Effectiveness After Cycles Reduction of Neoadjuvant Chemotherapy for Advanced Epithelial Ovarian, Fallopian and Primary Peritoneal Cancer

the time interval from randomization date to disease recurrence or progression date

the time interval from randomization date to death or end of study date

the time interval from randomization date to disease recurrence or progression except death date

Tumor response after neoadjuvant chemotherapy

Surgical response after interval debulking surgery

Tumor response after adjuvant chemotherapy

Size of post operative residual tumor on computed tomography (CT) after interval debulking surgery

Standardized uptake positron emission tomography (PET) CT

Scoring of quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Scoring of quality of life assessment using the EORTC ovarian cancer module (EORTC QLQ-Ov28)

Scoring of quality of life assessment using the Functional Assessment of Cancer Therapy (FACT-O)

Scoring of quality of life assessment using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

Evaluation of chemotherapy induced toxicity

Evaluation of optimal cytoreduction and extent of resection based on modified Korean Gynecologic Oncology Group (KGOG) operation record form and tumor burden index

Evaluation of difficulty of surgical skills based on surgical complexity score Minimal 0 to maxial 18 point. Each surgery will classified into low (point ≤3), intermediate (4-7), high (≥8) Higher value means more complex surgery.

Incidence of early complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System

Incidence of late complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System

Estimated blood loss (ml) based on Modified KGOG Operation Record Form

Operation time (min) based on Modified KGOG Operation Record Form

Transfusion (count by volume of transfused RBC) based on Modified KGOG Operation Record Form

days of hospitalization based on Modified KGOG Operation Record Form

days of management in intensive care unit based on Modified KGOG Operation Record Form

Seoul National University Hospital

Associate Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

1 oz tart cherry juice concentrate diluted in water up to 8oz.

¼ oz tart cherry juice concentrate diluted in water up to 8oz.

Tart Cherry Juice

Eve Rodler, MD

This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.

Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).

PRIMARY OBJECTIVE: I. Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.

SECONDARY OBJECTIVE:

I. Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.

II. Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.

III. Ascertain the tolerability and side effects of intake of high-dose and low-dose tart cherry juice OUTLINE: Tart cherry juice in both arms must begin ≤ 7 days from start of taxane therapy. During treatment, each participant in the high-dose group will consume 1 oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 196 oz). Each participant in the low-dose group will consume ¼ oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 49 oz). Participants will have follow-up visits at the conclusion of chemotherapy and at 12 months.

Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy

A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy

Number of participants between study arms experiencing PIPN using the 11-item peripheral neuropathy component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) survey.

Assessment of the severity of PIPN using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) neuropathy subscale survey and National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v.5) physician assessment.

Number of participants between arms experiencing dose reductions, delays, or discontinuations.

Number of participants between study arms ≥90% compliant with daily consumption of tart cherry juice.

Number of participants between study arms with adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5).

Eve Rodler

Principal Investigator

Durvalumab

Tremelimumab

Antineoplastic Agents, Immunological

1. Neoadjuvant treatment:

   Standard chemotherapy + Durvalumab + Tremelimumab Durvalumab : 1500mg q3 weeks (total 3 dosing) Tremelimumab : 75mg q 3 weeks (total 3 dosing) Chemotherapy regimen: Paclitaxel 175 mg/m2 , Carboplatin AUC 5-6 q3 weeks (total 3 dosing)
2. Interval debulking surgery
3. Adjuvant treatment:

Standard chemotherapy + Durvalumab Durvalumab; 1120mg q3 weeks (total 12 dosing) Chemotherapy regimen: Paclitaxel 175mg/m2, carboplatin AUC 5-6 q 3weeks (total3 dosing)

Neoadjuvant chemotherapy+Durvalumab+Tremelimumab

Jung-Yun Lee, MD., Ph.D

Myong Cheol Lim, MD, PH.D

Byoung-Gie Kim, MD, PH.D

Jae-Woen Kim,, PH.D

Jung-Yun Lee, MD, Ph.D

The primary objective of this trial is to evaluate the synergistic effects of durvalumab and tremelimumab plus chemotherapy in advanced-stage ovarian cancer.

Ovarian cancer is the deadliest gynecologic cancer. The current standard therapy is surgical cytoreduction followed by taxane-platinum combination chemotherapy. However, most patients with advanced-stage ovarian cancer will experience a relapse of disease. Therefore, there is an urgent need to improve outcomes of patients with this aggressive cancer.

Research hypothesis: Adding durvalumab and tremelimumab to current neoadjuvant chemotherapy (front-line therapy) in advanced-stage ovarian cancer can increase response rate and improve patient's outcome such as progression-free survival and overall survival with minimal effects on safety.

This study is single arm phase II study to evaluate efficacy and safety of durvalumab and tremelimumab and chemotherapy in treatment-naïve clinical stage IIIC/IV ovarian cancer.

A Phase II Study of Neoadjuvant Chemotherapy Plus Durvalumab (MEDI4736) and Tremelimumab in Advanced-stage Ovarian Cancer (TRU-D)

12-months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.

Response rate by RECIST version 1.1 after neoadjuvant chemotherapy(after the completion of 3rd cycle)

Immune-related response after neoadjuvant chemotherapy(after the completion of 3rd cycle)

Response rate by PERCIST after neoadjuvant chemotherapy(after the completion of 3rd cycle)

R0 rate of IDS(interval debulking surgery) after neoadjuvant chemotherapy(after the completion of 3rd cycle)

The rate of chemotherapy response score 3 after neoadjuvant chemotherapy(after the completion of 3rd cycle)

Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy

AstraZeneca

Samsung Genomic Institute

Samsung Medical Center

Korean Gynecologic Oncology Group

National Cancer Center, Korea

Yonsei University

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Hematinics

Liver Extracts

Device(s) will be surgically implanted in the peritoneal cavity. Up to three (3) M-Trap devices will be surgically implanted via laparotomy in the right and left paracolic (pelvic) gutters and behind segment 6 of the liver within the peritoneal cavity of the patient at the time of surgical resection. Patients will receive standard platinum-based chemotherapy. If the cancer is diagnosed to have recurred, M-Trap devices with captured tumor cells will be removed via minimally invasive surgery (laparoscopy).

M-Trap

Antonio Gil-Moreno, MD

M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients. The study objective is to assess the safety and the performance of the M-Trap device.

Prospective, multi-center, non-blinded, single-arm study

Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

Safety and Performance of Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

Number of devices implanted at conclusion of debulking surgery.

Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device

Reason that device removal was planned, regardless of whether or not it was completed.

The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites.

An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites, adjusted based on the breakdown of the historical control population by number of extended procedures

Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal

Device-related long-term adverse events and serious adverse events reported through 18 months

Procedure-related long-term adverse events and serious adverse events reported through 18 months

Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization.

MedPass International

MTrap, Inc.

Any adverse event (AE) observed was fully investigated by the Investigator and classified in line with the definitions of the ISO 14155:2011. AEs were collected from patients and their medical records at each follow-up interval (discharge, 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months).

M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Spain

Region of Enrollment

Staging is the process of finding out how much cancer is in a person's body and where it's located.

Stage IIIC: Cancer has spread to the peritoneum and the cancer in the peritoneum is larger than 2 centimeters and/or cancer has spread to lymph nodes in the abdomen.

Stage IVA: Cancer cells are found in extra fluid that has built up around the lungs.

Stage IVB: Cancer has spread to organs and tissues outside the abdomen, including lymph nodes in the groin.

Ovarian Cancer Stage

Eastern Cooperative Oncology Group GRADE 0 Fully active, able to carry on all pre-disease performance without restriction GRADE 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature GRADE 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours GRADE 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours GRADE 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair GRADE 5 Dead

ECOG Performance Status

Pregnancy

Primary debulking has no chemotherapy treatment prior to the debulking surgery. Interval debulking has 3 to 4 rounds of chemotherapy treatment prior to the debulking surgery with the aim of reducing the tumor burden prior to surgery.

Type of debulking procedure

All patients

Primary debulking

Interval debulking

Peritoneal cancer index (PCI) - assesses extent of peritoneal cancer in peritoneal cavity. Peritoneal cavity is divided in 13 well-defined regions. In each region, the size of the largest tumor nodule is measured. If no tumor is visualized, score is "0". If the largest tumor nodule is smaller than 0.5 cm, score is "1". If tumor measures between 0.5 cm and 5 cm, score is "2". If lesion is larger than 5 cm, the score is "3". If layering or a confluence of multiple small tumor nodules, score is "3". PCI is calculated by adding the scores of all regions together with a max of 39 (13×3).

Analysis on complete population and sub-analysis by type of debulking surgery.

Pre-debulking PCI

Measure Analysis Population Description: Analysis on complete population and sub-analysis by type of debulking surgery.

Post-debulking PCI

Pre-operative serum albumin

Pre-operative hemoglobin

1 extended procedure

2 extended procedures

3 or more extended procedures

Total number of extended procedures per the Patankar definition. Extended procedures of interest included lymphadenectomy, small bowel resection, colectomy, rectosigmoid resection, hepatic resection, bladder resection, diaphragm resection and cytoreduction.

Total number of extended procedures

Vice President, RA/QA/CA

H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)

M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.

Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events

Tumor cell capture in at least one device in patients determined to be recurrent and platinum-resistant

Platinum Resistant, Recurrent Patients

Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive

Platinum Sensitive, Recurrent Patients

Tumor cell capture in at least one device in patients who did not demonstrate recurrence

Non-recurrent

Tumor cell capture in at least one device in patients determined to be recurrent

All Recurrent Patients

Tumor cell capture in at least one device in all patients

All Patients

Assessment was completed in all patients who underwent successful device removal.

Performance: Number of Participants With Histological Evidence of Tumor Cell Capture

Safety: Number of Participants With Device-related Long-term Adverse Event Reporting

Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting

M-Trap Platinum Resistant Recurrent

Tumor cell capture in at least one device in patients determined to be non-recurrent

Tumor cell capture in at least one device in all patients determined to be recurrent

All patients with disease focalization scores reported

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reduction Of Cycles of neOadjuvant Chemotherapy for Advanced Epithelial Ovarian, Fallopian and Primary Peritoneal Cancer	NCT03693248	Ovarian Cancer ... Ovarian Cancer ... Fallopian Tube ... Peritoneal Canc...	Two cycles of n...	20 Years - 80 Years	Seoul National University Hospital
Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy	NCT06268665	Breast Cancer Breast Cancer S... Breast Cancer S... Breast Cancer S... Breast Cancer S... Invasive Breast... Ovarian Cancer Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ... Breast Cancer S... Breast Cancer I... Breast Cancer, ... Breast Cancer, ... Breast Cancer S... Breast Cancer S... Breast Cancer S... Breast Cancer S... Cancer, Breast Tumors, Breast Mammary Cancer Mammary Carcino... Breast Carcinom... Breast Neoplasm Malignant Breas... Malignant Tumor... Cancer of Ovary Ovary Cancer Ovary Neoplasm	Tart Cherry Jui...	18 Years -	University of California, Davis
A Phase II Study of Neoadjuvant Chemotherapy Plus Durvalumab (MEDI4736) and Tremelimumab in Advanced-stage Ovarian Cancer (TRU-D)	NCT03899610	Ovarian Cancer ... Ovarian Cancer ...	Neoadjuvant che...	20 Years -	Yonsei University
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer	NCT03085238	Ovarian Cancer ... Ovarian Cancer ...	M-Trap	18 Years -	MTrap, Inc.
Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer	NCT03579394	Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ...	Retarded IDS (I... Standard IDS (I...	18 Years - 99 Years	ARCAGY/ GINECO GROUP
Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer	NCT00945191	Ovarian Cancer ... Ovarian Cancer ...	CS-1008 Paclitaxel Carboplatin	18 Years -	Daiichi Sankyo
Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer	NCT03922776	Ovarian Cancer ... Fallopian Tube ... Fallopian Tube ... Ovarian Cancer ...	Blood sample co...	18 Years -	Centre Oscar Lambret

Spots Global Cancer Trial Database for ovarian cancer stage iiic