Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare 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

Reproductive Control Agents

All Drugs and Chemicals

Contraceptive Agents

Contraceptives, Oral

After randomization the participant is offered a referral to a genetic counselor.

The genetic counseling sessions are conducted by a licensed genetic counselor, certified by the American Board of Genetic Counseling and the American Board of Medical Genetics. This clinical counseling session may include, but is not limited to the following:

1. A review of medical and family history information to determine which genetic test (BRCA, HNPCC, p53, etc.), if any, is appropriate;
2. Discuss how the results - positive or negative - affect cancer risk
3. Discuss how cancer risk might be managed (surveillance, prophylactic surgery, oral contraceptives, etc.);
4. Discuss how the test is conducted and what the results might be (positive, negative, uncertain);
5. Discuss the disadvantages of genetic testing (cost, insurance coverage, worry about insurance discrimination, uncertain results, etc.) and the psychological and emotional issues surrounding testing, etc.

genetic counseling

Nicole Urban, ScD

The primary purpose of this study is to evaluate the effect of systematic identification and genetic counseling referral on rates of bilateral salpingo-oophorectomy (surgery to remove both fallopian tubes and ovaries) in women having mammograms at Swedish Medical Center in Seattle, WA.

Prevention of Ovarian Cancer in Women Participating in Mammography

Swedish Medical Center

Fred Hutchinson Cancer Center

Digestive System Diseases

Symptoms and General Pathology

Wounds and Injuries

Colorectal Neoplasms

Hyperthermia

Fever

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

Anti-Infective Agents

Mitomycins

Mitomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin

ARM B: Standard surgey without HIPEC CO2 The arm B is with standard surgery without HIPEC CO2

Prophylactic surgery plus HIPEC CO2 performed with mitomycin

HIPEC CO2 surgery

Standard surgery

Fabio Pacelli, MD

Chiara Gerardi

Michele Simone

Giovanni Ciaccio

Maurizio Rizzo

Giovanni Ferrari, MD

Luigi Boni

Carmine Antropoli

Francesco Corcione

Antonino Agrusa

Roberto Persiani

Luigi Bonavina

Francesca Bazzocchi

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center

The HIPEC CO2 regimen will be as reported below:

mitomycin: (total dose of 35 mg/mq, physiologic solution 0.9%) administrated 50% at time 0 from start of HIPEC CO2 treatment (17.5 mg/mq), 25% (8.8 mg/mq) after 30 minutes and the last dose 25% after 60 minutes. Recommended temperature for HIPEC treatment is 41-42 °C for 90 minutes.

Adjuvant treatment consists of a 6 months chemotherapy after surgery. It is possible to choose between Oxaliplatin, Capecitabine (XELOX) or Oxaliplatin, Fluorouracil, Leucovorin (FOLFOX-4) Patients affected by CRC at high risk of developing peritoneal carcinomatosis will be randomized in the study.

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery

Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.

Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Colorectal Carcinoma at High Risk Peritoneal Carcinomatosis. Short and Long-term Outcomes. CHECK STUDY

The primary efficacy endpoint is LRFS defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.

Disease Free Survival (DFS) DFS is defined as the time from randomization to the date of first local relapse, distant relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.

OS is defined as the time from randomization to death for any cause.

evaluated during and after surgery, graded according to the NCI-CTAE version 4.03 for AE related to chemotherapy and according to Clavien Dindo for surgery complications

patients performing the adjuvant chemotherapy

Mario Negri Institute for Pharmacological Research

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Cisplatin

Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin

Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v

Surgery plus HIPEC CO2

Andrea Di Giorgio, MD

Erica Rulli

Alberto Biondi

Andrea Di Giorgio

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
* comparator: standard surgery

Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility in both arms.

Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables.

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables.

The primary objective of the study is to compare the efficacy of prophylactic surgery (radical gastric resection, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 versus standard surgery in terms of disease free survival (DFS).

Patients affected by gastric carcinoma at high risk of developing peritoneal carcinomatosis will be randomized in this study.

This is a phase III randomized, multicenter study with two different arm:

* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
* comparator: standard surgery

Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study

Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Gastric Carcinoma at High Risk of Developing Peritoneal Carcinomatosis. Short and Long-term Outcomes Evaluation.A Collaborative Randomized Controlled Trial of: ACOI, FONDAZIONE AIOM, SIC, SICE, SICO. GOETH STUDY

The primary efficacy endpoint is DFS defined as the time from randomization to the date of first local relapse or distant relapse or peritoneal carcinomatosis or death for any cause, whichever comes first.

Overall Survival (OS) defined as the time from randomization to the death for any cause

Local recurrence free survival (LRFS) defined as the time from randomization defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.

morbidity evaluated during and after surgery graded according to the NCI-CTAE version 4.03 for AE related to chemotherapy and according to Clavien Dindo for surgery complications

number of patients performing the adjuvant chemotherapy.

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Cystadenocarcinoma, Serous

Hereditary Breast and Ovarian Cancer Syndrome

Syndrome

Breast Neoplasms

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Breast Diseases

Skin Diseases

Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer.

Radical fimbriectomy. Histopathology SEE-FIM

Laparoscopic bilateral radical fimbriectomy :

Complete resection of the tubes, from the uterine tube (up against the uterus) to the fimbriae, with resection of the part of the ovary adjacent to the ovarian fimbriae (adhering to the ovary)

Radical fimbriectomy

Anatomopathological study of surgical specimens

Histopathology SEE-FIM

Carlos MARTINEZ-GOMEZ, MD

Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.

Most of ovarian carcinomas related to BRCA 1 or 2 mutations are of fallopian tube origin and especially from its distant part called the fimbria. These tubal, ovarian or primary peritoneal carcinomas are quite always of high grade serous type. They cannot be effectively screened due to the quickness of their evolution. In this context, a laparoscopic bilateral salpingo-oophorectomy (BSO) is the recommended prophylactic procedure.

Some BRCA-mutated women are reluctant to undergo this procedure considering the numerous adverse effects on body and quality of life, especially when hormonal replacement is forbidden. This refusal makes them at risk of developing a serous pelvic carcinoma.

The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion

Radical Fimbriectomy for Young BRCA Mutation Carriers

Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma

Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause

Morbidity will be assessed according to the Clavien-Dindo classification up to 30 days after the procedure and according to the NCI-CTCAE v4.0 grading scale beyond that time

Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens

Number of cases of breast cancer or breast cancer recurrence observed

Number of oophorectomies and time between fimbriectomy and oophorectomy Complications according to NCI-CTCAE v4.0 grading scale

Immunostaining is realised on sections of ovary portion, fimbriae and fallopian tubes, then tumoral zones are selected for spatially resolved gun microproteomic analysis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Ovarian Cancer in Women Participating in Mammography	NCT01851109	Epithelial Ovar...	genetic counsel...	35 Years -	Fred Hutchinson Cancer Center
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.	NCT03914820	Colorectal Neop...	HIPEC CO2 surge... Standard surger... Mitomycin	18 Years - 75 Years	Mario Negri Institute for Pharmacological Research
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study	NCT03917173	Stomach Neoplas...	Surgery plus HI... Standard surger...	18 Years - 75 Years	Mario Negri Institute for Pharmacological Research
Radical Fimbriectomy for Young BRCA Mutation Carriers	NCT01608074	BRCA1 Mutation BRCA2 Mutation Hereditary Brea...	Radical fimbrie... Histopathology ...	35 Years -	Centre Oscar Lambret

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