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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    298
  • sponsor
    Seoul National University Hospital
Updated on 20 February 2022
cancer
remission
ascites
metastasis
neutrophil count
cancer chemotherapy
adenocarcinoma
cancer antigen 125
l alanine
peritoneal cancer
primary peritoneal carcinoma
tumor debulking
cytoreductive surgery

Summary

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.

Description

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.

Details
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

Eligibility

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
Pregnancy
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
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