Reduction Of Cycles of neOadjuvant Chemotherapy for Advanced Epithelial Ovarian, Fallopian and Primary Peritoneal Cancer (ROCOCO)

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Seoul National University Hospital
Updated on 20 February 2022
neutrophil count
cancer chemotherapy
cancer antigen 125
l alanine
peritoneal cancer
primary peritoneal carcinoma
tumor debulking
cytoreductive surgery


Te hypothesized that two cycles of neoadjuvant chemotherapy followed by interval debulking surgery would improve survival in advanced epithelial ovarian, fallopian, and primary peritoneal cancer because reduction of one cycle of chemotherapy can lead to the removal of more tumor burden, compared with three cycles of neoadjuvant chemotherapy.

So the investigators aim to compare survival, rate of successful optimal cytoreductive surgery, post-operative complications, and quality of life between two and three cycles of neoadjuvant chemotherapy followed by interval debulking surgery for advanced epithelial ovarian, fallopian, and primary peritoneal cancer.


Primary debulking surgery (PDS) followed by adjuvant chemotherapy is the standard treatment for advanced epithelial ovarian, fallopian and primary peritoneal cancer. However, three or four cycles of neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS) has been introduced in clinical setting because four randomized controlled trials related have shown a lower rate of complications in NAC followed by IDS despite the similar efficacy between PDS and NAC followed by IDS in advanced epithelial ovarian, fallopian and primary peritoneal cancers. However, these trials have some limitations that the rate of optimal cytoreduction defined as the size of residual tumor <1 cm was about 40%, which was a disappointed result not showing the surgical effect improving survival. Nevertheless, more treatment strategies using NAC followed by IDS should be investigated because NAC followed by IDS has been already known as another standard treatment due to the safety.

A recent meta-analysis has reported that reduction of one cycle of neoadjuvant chemotherapy may increase overall survival of 4.1 months because it can induce surgical resection of more visible tumors with drug-resistant. Moreover, a related clinical trial has shown that hyperthermic intraperitoneal chemotherapy (HIPEC) may increase survival in patients with advanced ovarian cancer who received three cycles of neoadjuvant chemotherapy because HIPEC can kill drug-resistant invisible tumor cells which were not resected during IDS. Thus, the investigators designed a phase 3, multicenter, randomized controlled trial for comparing survival, clinical outcomes and quality of life between two and three cycles of NAC followed by IDS, and thereby will investigate the efficacy and safety of reduction of one cycle of NAC.

Condition Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV, Fallopian Tube Cancer, Peritoneal Cancer
Treatment Two cycles of neoadjuvant chemotherapy
Clinical Study IdentifierNCT03693248
SponsorSeoul National University Hospital
Last Modified on20 February 2022


Yes No Not Sure

Inclusion Criteria

Age: 20-80 years old
Advanced epithelial ovarian, fallopian or primary peritoneal cancer diagnosed with the following methods
Histologic confirmation by diagnostic laparoscopic or laparotomy Histologic malignancy originated from female genital tract on fine needle aspiration if histological confirmation is difficult or cytologic confirmation of adenocarcinoma in ascites if fine needle aspiration is difficult, meeting the following criteria
Existence of the pelvic or ovarian mass
Identification of tumor >2 cm beyond the pelvis on CT, malignant pleural effusion by thoracentesis, extraperitoneal lymph node metastasis (cardio-phrenic, internal mammary, mediastinal, para-tracheal, supraclavicular lymph nodes or inguinal lymph nodes)
Cancer antigen 125 (CA-125, kU/L)/carcinoembryonic antigen (CEA, ng/ml) >25
if CA-125 (kU/L)/CEA (ng/ml) is 25 or less, no primary lesion on colonoscopy, gastroscopy and mammography within six weeks before randomization
International Federation of Gynecology and Obstetrics (FIGO) stage IIIC to IVB disease
World Health Organization performance status 0-2
The following criteria should be met if synchronous or metachronous tumors exists
Complete remission of metachronous malignancy for at least 5 years
Follicular or papillary thyroid cancer treated completely with only surgery as
a synchronous tumor
Early gastric or colon cancer treated completely with only endoscopic mucosal
resection as a synchronous tumor
\. Normal hematologic, renal and liver function with the following criteria
White blood cell (WBC) 3,000/ul Absolute neutrophil count (ANC) 1,500/ul
Platelet 100103/ul Aspartate aminotransferase (AST) 100 IU/L Alanine
aminotransferase (ALT) 100 IU/L Serum total bilirubin 1.5 mg/dL Serum
creatinine 1.5 mg/dL
\. Absence of psychological, and socioeconomic limitations affecting
participation to this trial
\. Informed consent

Exclusion Criteria

Diagnosis of metachronous malignancy within five years before enrollment
Synchronous tumors except follicular or papillary thyroid cancer treated completely with only surgery and early gastric or colon cancer treated completely with only endoscopic mucosal resection
Carcinoma in situ, non-epithelial, or borderline tumor in ovary, fallopian tube, and peritoneum
Medical conditions (hypertension, diabetes mellitus, infectious or cardiac disease etc.) influencing on survival
Clinical evidence of brain or leptomeningeal metastasis, bone metastasis
Other treatments affecting clinical outcomes during participation to this trial (hyperthermic intraperitoneal chemotherapy, onco-thermia, herbal medicine, etc.)
No informed consent
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note