Condition category
Cancer
Date applied
15/11/2019
Date assigned
25/11/2019
Last edited
22/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Ovarian cancer is mostly diagnosed at advanced stage. Better survival is achieved through surgery to completely remove the ovaries followed by chemotherapy. In some cases where surgical removal is difficult and dangerous, chemotherapy is given before surgery to try and reduce the size of the affected area (known as preoperative or neoadjuvant chemotherapy).
The study aims to examine the usefulness of preoperative chemotherapy.

Who can participate?
Patients with ovarian and peritoneal cancers accompanied with diaphragmatic lesions who underwent standard surgery combined with diaphragmatic surgery, with or without preoperative chemotherapy, at two related institutions from January 2010 to December 2013

What does the study involve?
Medical records are analysed to assess the cancer recurrence period, recurrence site, and the date of last confirmed survival.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Tokyo Jikei University School of Medicine, Japan

When is the study starting and how long is it expected to run for?
April 2019 to November 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Motoaki Saito
smotoaki@jikei.ac.jp

Trial website

Contact information

Type

Scientific

Primary contact

Mr Motoaki Saito

ORCID ID

http://orcid.org/0000-0001-6764-8459

Contact details

6-41-2 Aoto
Katsushika-ku
Tokyo
125-8506
Japan
81-3-3603-2111
smotoaki@jikei.ac.jp

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

30-466(9487)

Study information

Scientific title

Neoadjuvant chemotherapy for patients with diaphragmatic lesions: A prognostic postoperative analysis

Acronym

NAC-DIAL

Study hypothesis

The aim is to analyse the prognosis of patients who underwent primary debulking surgery (PDS) and those who underwent interval debulking surgery (IDS) following four courses of paclitaxel + carboplatin (PC) as preoperative (neoadjuvant) chemotherapy to examine the usefulness of preoperative chemotherapy

Ethics approval

Approved 08/04/2019, Institutional review board of Tokyo Jikei University School of Medicine (3-25-8 Nishi-Shimbashi, Minato-ku Tokyo 105-8461 Japan; +81-3-3433-1111; rinri@jikei.ac.jp), ref: [30-466(9487)]

Study design

Retrospective cohort study

Primary study design

Observational

Secondary study design

Retrospective cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Ovarian or peritoneal cancer

Intervention

Between January 2010 and December 2013, patients with epithelial ovarian and peritoneal cancers accompanied with diaphragmatic lesions underwent standard surgery combined with diaphragmatic surgery at two related institutions.

IDS was performed in patients in whom partial response or greater was achieved with six courses of postoperative PC following PDS or with four courses of PC following NAC; additional four courses of PC were administered following IDS. Furthermore, patients in the NAC group were defined as those in whom complete excision was considered difficult due to a tumour in the right triangular ligament, which was identified after intraperitoneal exploration was performed by surgery rather than based on diagnostic imaging, and those who had residual lesions of the diaphragm on pre-IDS diagnostic imaging and simultaneously underwent surgery of the diaphragm and IDS. Residual tumour was determined based on macroscopic findings by intraperitoneal exploration.

From the medical records, we surveyed the recurrence period, recurrence site, and the date of last confirmed survival, and analysed prognosis.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Survival curve measured using up to date medical records

Secondary outcome measures

1. Overall survival measured using up to date medical records
2. Progression-free survival measured using up to date medical records

Overall trial start date

01/04/2019

Overall trial end date

01/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 20 years or above
2. Female
3. Attended surgery between January 2010 and December 2013

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

45

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2019

Recruitment end date

01/11/2019

Locations

Countries of recruitment

Japan

Trial participating centre

Tokyo Jikei University School of Medicine
3-25-8 Nishi-Shimbashi Minato-ku
Tokyo
105-8461
Japan

Sponsor information

Organisation

The Jikei University School of Medicine

Sponsor details

Department of Obstetrics and Gynecology
3-25-8 Nishi-Shimbashi
Minato-ku
Tokyo
105-8461 Japan
Japan
+81 3-3433-1111 ext. 3521
smotoaki@jikei.ac.jp

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/11/2019: Trial’s existence confirmed by Tokyo Jikei University School of Medicine