Long term outcomes in patients with ovarian or abdominal cancer who underwent chemotherapy either before or after surgery to remove the affected areas

ISRCTN	ISRCTN81171658
DOI	https://doi.org/10.1186/ISRCTN81171658
Secondary identifying numbers	30-466(9487)

Submission date: 15/11/2019
Registration date: 25/11/2019
Last edited: 30/12/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mr Motoaki Saito
Scientific

6-41-2 Aoto
Katsushika-ku
Tokyo
125-8506
Japan

ORCID ID	0000-0001-6764-8459
Phone	81-3-3603-2111
Email	smotoaki@jikei.ac.jp

Study information

Study design	Retrospective cohort study
Primary study design	Observational
Secondary study design	Retrospective cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	Neoadjuvant chemotherapy for patients with diaphragmatic lesions: A prognostic postoperative analysis
Study acronym	NAC-DIAL
Study objectives	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(s)	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)]
Health condition(s) or problem(s) studied	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
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 study start date	01/04/2019
Completion date	01/11/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	45
Total final enrolment	45
Key inclusion criteria	1. Aged 20 years or above 2. Female 3. Attended surgery between January 2010 and December 2013
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2019
Date of final enrolment	01/11/2019

Locations

Countries of recruitment

Japan

Study participating centre

Tokyo Jikei University School of Medicine

3-25-8 Nishi-Shimbashi
Minato-ku
Tokyo
105-8461
Japan

Sponsor information

The Jikei University School of Medicine
Hospital/treatment centre

Department of Obstetrics and Gynecology
3-25-8 Nishi-Shimbashi
Minato-ku
Tokyo
105-8461 Japan
Japan

Phone	+81 3-3433-1111 ext. 3521
Email	smotoaki@jikei.ac.jp
"ROR"	https://ror.org/039ygjf22

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/12/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2020	30/12/2022	Yes	No

Editorial Notes

30/12/2022: Publication reference and total final enrolment added.
22/11/2019: Trial’s existence confirmed by Tokyo Jikei University School of Medicine