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Ovarian Cancer Stage IIICPhase 3ROCOCONCT03693248

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

A Phase 3 study testing Two cycles of neoadjuvant chemotherapy in people with Ovarian Cancer Stage IIIC and Ovarian Cancer Stage IV, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 80 years, women only
What is being tested?
Two cycles of neoadjuvant chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
1 siteSouth Korea
Study dates
19 Dec 2018to 31 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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
  • Informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul

    Moon Kyoung Bae, 82-2-2072-2643, mose79bmk@naver.com

    Soo Jin Park, MD, MD, soojin.mdpark@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: Multi-center, Randomized Controlled, Phase III Trials to Evaluate the Safety and Effectiveness After Cycles Reduction of Neoadjuvant Chemotherapy for Advanced Epithelial Ovarian, Fallopian and Primary Peritoneal Cancer

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.

Read the detailed 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.

Being tested
Two cycles of neoadjuvant chemotherapy
Keywords
advanced ovarian cancer, advanced fallopian cancer, advanced peritoneal cancer, neoadjuvant chemotherapy, cycles of chemotherapy, survival
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Two cycles of neoadjuvant chemotherapyDrug

    Also called paclitaxel and carboplatin

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

Study groups in NCT03693248
Study groupRoleWhat they receive
Two cycles of neoadjuvant chemotherapyExperimental* 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.
Receives: Drug: Two cycles of neoadjuvant chemotherapy
Three cycles of neoadjuvant chemotherapyNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

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

    Measured: 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)

  1. Overall survival

    the time interval from randomization date to death or end of study date

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

  2. Time to progression

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

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

  3. Tumor response 1

    Tumor response after neoadjuvant chemotherapy

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

  4. Tumor response 2

    Surgical response after interval debulking surgery

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

  5. Tumor response 3

    Tumor response after adjuvant chemotherapy

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

  6. Radiologic evaluation of residual tumor

    Size of post operative residual tumor on computed tomography (CT) after interval debulking surgery

    Measured: 3 weeks after interval debulking surgery, up to 6 weeks

  7. Functional assessment of residual tumor

    Standardized uptake positron emission tomography (PET) CT

    Measured: 3 weeks after neoadjuvant chemotherapy, up to 6 weeks

  8. Assessment of quality of life1

    Scoring of quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Measured: From the date of screening to the date before treatment start, 3 weeks after interval debulking surgery within 6 weeks, 3 weeks after completion of adjuvant chemotherapy up to 6 weeks, on date of visit at 6 months after completion of primary treatment

  9. Assessment of quality of life2

    Scoring of quality of life assessment using the EORTC ovarian cancer module (EORTC QLQ-Ov28)

    Measured: From the date of screening to the date before treatment start, 3 weeks after interval debulking surgery within 6 weeks, 3 weeks after completion of adjuvant chemotherapy up to 6 weeks, on date of visit at 6 months after completion of primary treatment

  10. Assessment of quality of life3

    Scoring of quality of life assessment using the Functional Assessment of Cancer Therapy (FACT-O)

    Measured: From the date of screening to the date before treatment start, 3 weeks after interval debulking surgery within 6 weeks, 3 weeks after completion of adjuvant chemotherapy up to 6 weeks, on date of visit at 6 months after completion of primary treatment

  11. Assessment of quality of life4

    Scoring of quality of life assessment using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

    Measured: From the date of screening to the date before treatment start, 3 weeks after interval debulking surgery within 6 weeks, 3 weeks after completion of adjuvant chemotherapy up to 6 weeks, on date of visit at 6 months after completion of primary treatment

  12. Adverse events

    Evaluation of chemotherapy induced toxicity

    Measured: From the date of first day of chemotherapy to the day before starting next cycle. Each cycle is 21 days.

  13. Success rate of optimal cytoreduction

    Evaluation of optimal cytoreduction and extent of resection based on modified Korean Gynecologic Oncology Group (KGOG) operation record form and tumor burden index

    Measured: On the date of completion of interval debulking surgery, up to 24 hours

  14. Surgical complexity score (SCS)

    Evaluation of difficulty of surgical skills based on surgical complexity score Minimal 0 to maxial 18 point. Each surgery will classified into low (point ≤3), intermediate (4-7), high (≥8) Higher value means more complex surgery.

    Measured: On the date of completion of interval debulking surgery, up to 24 hours

  15. Postoperative complications 1

    Incidence of early complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System

    Measured: Early complications: after interval debulking surgery, up to 30 days

  16. Postoperative complications 2

    Incidence of late complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System

    Measured: Late complications: 31 days after interval debulking surgery through study completion, an average of 1 year

  17. Estimated blood loss

    Estimated blood loss (ml) based on Modified KGOG Operation Record Form

    Measured: after interval debulking surgery up to 3 months

  18. Operation time

    Operation time (min) based on Modified KGOG Operation Record Form

    Measured: after interval debulking surgery up to 3 months

  19. Transfusion

    Transfusion (count by volume of transfused RBC) based on Modified KGOG Operation Record Form

    Measured: after interval debulking surgery up to 3 months

  20. days of hospitalization

    days of hospitalization based on Modified KGOG Operation Record Form

    Measured: after interval debulking surgery up to 3 months

  21. days of management in intensive care unit

    days of management in intensive care unit based on Modified KGOG Operation Record Form

    Measured: after interval debulking surgery up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study start19 Dec 2018
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparison of clinical outcomes between two and three cycles of neoadjuvant chemotherapy followed by interval debulking surgery.
Masking
None (open label)
Enrolment
298 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03693248
Sponsor's protocol ID
2018-0228
Acronym
ROCOCO
Status last verified
Dec 2019
First submitted
13 Jul 2018
Last updated
10 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32375688

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Two cycles of neoadjuvant chemotherapy in people with Ovarian Cancer Stage IIIC and Ovarian Cancer Stage IV, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hee Seung Kim, MD/PhD (82-2-2072-4863, bboddi0311@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03693248, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.

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