## Protocol Section
### Identification Module
**NCT ID:** NCT01809379

**Brief Title:** Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer

**Official Title:** Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase II Clinical Trial

#### Organization Study ID Info
**ID:** PIPAC-OV1
#### Organization
**Class:** OTHER
**Full Name:** Ruhr University of Bochum
### Status Module
#### Completion Date
**Date:** 2014-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-07-08

**Type:** ACTUAL

**Last Update Submit Date:** 2022-07-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-03

**Type:** ACTUAL

#### Start Date
**Date:** 2013-02

**Status Verified Date:** 2022-07

#### Study First Post Date
**Date:** 2013-03-12
**Type:** ESTIMATED
**Study First Submit Date:** 2013-03-08
**Study First Submit QC Date:** 2013-03-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ruhr University of Bochum

#### Responsible Party

**Investigator Affiliation:** Ruhr University of Bochum

**Investigator Full Name:** Clemens Tempfer

**Investigator Title:** Prof. Dr. med. Clemens Tempfer, MBA

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

**Detailed Description:** This study aims to investigate the therapeutic efficacy of PIPAC using doxorubicin and cisplatin in women with recurrent ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin.

### Conditions Module

**Conditions:**

- Recurrent Ovarian Cancer

**Keywords:**

- ovarian cancer, recurrent, chemotherapy, intraperitoneal

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 69

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intraperitoneal chemotherapy with cisplatin at a dose of 7.5 mg/m2 body surface in a 150 ml NaCl 0.9% and doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution with a flow of 30 ml/min and a max upstream pressure of 200 psi.

**Intervention Names:**

- Drug: chemotherapy with doxorubicin and cisplatin

**Label:** intraperitoneal chemotherapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- intraperitoneal chemotherapy

**Description:** intraperitoneal chemotherapy applied as an aerosol and under pressure

**Name:** chemotherapy with doxorubicin and cisplatin

**Other Names:**

- CISPLATIN Teva, Adrimedac

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** various measures of response to therapy on the clinical, biochemical, and histological level

**Measure:** tumor apoptosis assessment, videolaparoscopy assessment of response, CA 125 assessment of response

**Time Frame:** 6 months

#### Primary Outcomes

**Description:** The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.

**Measure:** Clinical Benefit Rate

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy complications postoperative until hospital discharge, re-admission to hospital, death

**Measure:** safety

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* at least 2 lines of previous chemotherapy
* recurrent ovarian cancer
* patient is mobile
* informed consent

Exclusion Criteria:

* ileus
* necessity of parenteral nutrition

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bochum

**Country:** Germany

**Facility:** Ruhr University Bochum

**State:** NRW

**Zip:** 44623

#### Overall Officials

**Official 1:**

**Affiliation:** Runr University Bochum

**Name:** Clemens Tempfer, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18.

**PMID:** 25701703

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrent

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

### Condition Browse Module - Meshes

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000077216

- Term: Carcinoma, Ovarian Epithelial

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000059005

- Term: Topoisomerase II Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M7492

- Name: Doxorubicin

- Relevance: HIGH

- As Found: Women

- ID: M227339

- Name: Liposomal doxorubicin

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M6182

- Name: Cisplatin

- Relevance: HIGH

- As Found: High

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002945

- Term: Cisplatin

- ID: D000004317

- Term: Doxorubicin

### Misc Info Module

- Version Holder: 2024-05-24
