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

NCT03693248 | Unknown Phase 3 DMC

• 1 other identifier: 2018-0228
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

advanced ovarian cancer; advanced fallopian cancer; advanced peritoneal cancer; neoadjuvant chemotherapy; cycles of chemotherapy; survival

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  the time interval from randomization date to disease recurrence or progression date

  From date of randomization until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 60 months

Secondary Outcomes (21)

• Overall survival

  From the date of randomization until death due to any cause, assessed up to 60 months

• Time to progression

  From date of randomization until the date of first documented progression in the absence of death by any cause, assessed up to 60 months

• Tumor response 1

  3 weeks after completion of neoadjuvant chemotherapy, up to 6 weeks

• Tumor response 2

  3 weeks after completion of interval debulking surgery, up to 6 weeks

• Tumor response 3

  3 weeks after completion of adjuvant chemotherapy, up to 6 weeks

Study Arms (2)

Two cycles of neoadjuvant chemotherapy

EXPERIMENTAL

* Paclitaxel (175mg/m2) and carboplatin (AUC 5.0 or 6.0) IV, D1, every three weeks. * Two cycles of neoadjuvant chemotherapy and four cycles of adjuvant chemotherapy.

Drug: Two cycles of neoadjuvant chemotherapy

Three cycles of neoadjuvant chemotherapy

NO INTERVENTION

* Paclitaxel (175mg/m2) and carboplatin (AUC 5.0 or 6.0) IV, D1, every three weeks. * Three cycles of neoadjuvant chemotherapy and three cycles of adjuvant chemotherapy.

Interventions

Two cycles of neoadjuvant chemotherapy DRUG

Two and three cycles of neoadjuvant chemotherapy will be administered in experimental and control groups, respectively

Also known as: paclitaxel and carboplatin

Two cycles of neoadjuvant chemotherapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ② 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.
• ① Complete remission of metachronous malignancy for at least 5 years
• ② Follicular or papillary thyroid cancer treated completely with only surgery as a synchronous tumor
• ③ 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 ≥100×103/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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Park SJ, Shim SH, Ji YI, Kwon SH, Lee EJ, Lee M, Chang SJ, Park S, Kim SY, Lee SJ, Kim JW, Roh JW, Lee SH, Song T, Kim HS. Reduction of cycles of neoadjuvant chemotherapy for advanced epithelial ovarian, fallopian or primary peritoneal cancer (ROCOCO): study protocol for a phase III randomized controlled trial. BMC Cancer. 2020 May 6;20(1):385. doi: 10.1186/s12885-020-06886-2.

  PMID: 32375688 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Hee Seung Kim, MD/PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Seung Kim, MD/PhD

CONTACT

82-2-2072-4863; bboddi0311@gmail.com

Soo Jin Park, MD

CONTACT

82-2-2072-4863; soojin.mdpark@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Comparison of clinical outcomes between two and three cycles of neoadjuvant chemotherapy followed by interval debulking surgery.

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: October 2, 2018
• Study Start: December 19, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

KR (1)