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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 30-466(9487) |
| Sponsor | The Jikei University School of Medicine |
| Funder | Investigator initiated and funded |
- 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
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
Scientific
6-41-2 Aoto
Katsushika-ku
Tokyo
125-8506
Japan
 ORCID ID |
0000-0001-6764-8459 |
|---|---|
| Phone | 81-3-3603-2111 |
| smotoaki@jikei.ac.jp |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective cohort study |
| Secondary study design | Retrospective cohort study |
| Study type | Participant information sheet |
| 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(s) |
Survival curve measured using up to date medical records |
| Key secondary outcome measure(s) |
1. Overall survival measured using up to date medical records |
| Completion date | 01/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Minato-ku
Tokyo
105-8461
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
