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Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSION IV)

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ClinicalTrials.gov Identifier: NCT02986568
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Hee Seung Kim, Seoul National University Hospital

Brief Summary:
The purpose of this study is to compare standard treatment and fusion ontogenetic surgery (total mesometrial resection, laterally extended endopelvic resection, peritoneal mesometrial resection) for gynecologic cancer in order to evaluate treatment response, adverse effect and survival.

Condition or disease Intervention/treatment Phase
Cervical Cancer Uterine Cancer Drug: Cisplatin Procedure: Peritoneal mesometrial resection Procedure: Radical hysterectomy Radiation: Concurrent chemoradiation therapy (CCRT) Procedure: Laterally extended endopelvic resection, Total mesometrial resection Procedure: Total mesometrial resection Drug: 5-fluorouracil, Cisplatin Drug: Doxorubicin, Cisplatin Procedure: Staging operation Radiation: Radiotherapy or Concurrent chemoradiation therapy (CCRT) Not Applicable

Detailed Description:

Fujii method and ontogenetic surgery are the surgical method of radical hysterectomy that can preserve pelvic organ function as much as possible.

Fujii method has advantage of preserving pelvic autonomic nerve with radical resection of tissue under parametrium. And ontogenetic surgery has advantage of reducing need of radiation therapy by radical resection of tissue above parametrium.

This study is prospective study for fusion ontogenetic surgery that has the advantage of both Fujji method and ontogenetic surgery.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Study for Comparing the Efficacy Between the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSION Trial IV)
Study Start Date : May 2016
Estimated Primary Completion Date : December 2023

Arm Intervention/treatment
Experimental: Ontogenetic surgery - Early cervical cacner
Cervical cancer patients, FIGO stage IB1-IIA2
Drug: Cisplatin
If tumor sized ≥ 5cm, undergo neoadjuvant chemotherapy with Cisplatin before surgery. (40mg/m2 on day 1 of each 7 day cycle for 5 cycles)

Procedure: Total mesometrial resection

If tumor size < 5cm, perform Fusion Total mesometrial resection (TMMR)

If tumor sized ≥ 5cm, perform Fusion TMMR after neoadjuvant chemotherapy with cisplatin as above.


Drug: 5-fluorouracil, Cisplatin

After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy with 5-fluorouracil and cisplatin. (5-fluorouracil 1000mg/m2 on day 1-5 and Cisplatin 60mg/m2 on day 1 of each 21 day cycle)

If not, no adjuvant therapy.


Experimental: Ontogenetic surgery - Advanced cervical cancer
Cervical cancer patients, FIGO stage IIB- IVA
Drug: Cisplatin
Before surgery, neoadjuvant chemotherapy with cisplatin (40mg/m2 on day 1 of each 7 day cycle for 5 cycles) is performed.

Procedure: Laterally extended endopelvic resection, Total mesometrial resection

After neoadjuvant chemotherapy, if pelvic wall invasion is absent, perform Fusion Total mesometrial resection (TMMR).

If pelvic wall invasion is present, perform Fusion Laterally extended endopelvic resection (LEER) with preserving bladder, rectum and anus.


Drug: 5-fluorouracil, Cisplatin

After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy with 5-fluorouracil and cisplatin. (5-fluorouracil 1000mg/m2 on day 1-5 and Cisplatin 60mg/m2 on day 1 of each 21 day cycle)

If not, no adjuvant therapy.


Experimental: Ontogenetic surgery - Uterine cancer
Uterine cancer patients, FIGO stage IA, grade3, IB-IVA
Procedure: Peritoneal mesometrial resection
Perform Fusion Peritoneal mesometrial resection (PMMR).

Drug: Doxorubicin, Cisplatin

After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy with doxorubicin and cisplatin. (Doxorubin 60mg/m2 and Cisplatin 50mg/m2 on day 1 of each 21 day cycle)

If not, no adjuvant therapy.


Active Comparator: Standard treatment- Early cervical cancer
Cervical cancer patients, FIGO stage IB1-IIA2
Procedure: Radical hysterectomy
Type C radical hysterectomy.

Radiation: Concurrent chemoradiation therapy (CCRT)
If risk factor is reported in pathologic report, undergo adjuvant CCRT. (radiotherapy with Cisplatin 40mg/m2 on day 1 of each 7 day cycle)

Active Comparator: Standard treatment - Advanced cervical cancer
Cervical cancer patients, FIGO stage IIB- IVA
Radiation: Concurrent chemoradiation therapy (CCRT)
Radiotherapy with Cisplatin 40mg/m2 on day 1 of each 7 day cycle

Active Comparator: Standard treatment - Uterine cancer
Uterine cancer patients, FIGO stage IA grade3, IB-IVA
Procedure: Staging operation
Perform surgical staging include hysterectomy, bilateral salpingo-oophorectomy, pelvic lymph node dissection and para-aortic lymph node dissection.

Radiation: Radiotherapy or Concurrent chemoradiation therapy (CCRT)
Undergo adjuvant therapy after surgical staging. Radiotherapy only or CCRT (radiotherapy with Cisplatin 40mg/m2 on day 1 of each 7 day cycle)




Primary Outcome Measures :
  1. Intraoperative complications [ Time Frame: Intraoperative ]
  2. Acute complications related with surgery [ Time Frame: Average 10 days after surgery. ]
  3. Chronic complications related with surgery [ Time Frame: through study completion, an average of 5 years ]
    lymphocele, lymphedema, thrombosis, infection, etc.

  4. Time period for recovering normal voiding function [ Time Frame: postoperative (up to 6 month) ]
    Check residual urine. Keep CIC until residual urine < 100cc


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: through study completion, an average of 5 years ]
  2. Overall survival [ Time Frame: through study completion, an average of 5 years ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female, Age ≥ 20 years
  • Patients with primary cervical cancer (FIGO stage IB1-IVA)
  • Patients with primary uterine cancer (FIGO stage IA, grade 3, IB-IVA)
  • Patients who signed an approved informed consent

Exclusion Criteria:

  • Female, Age < 20 years
  • Patients who refused to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986568


Contacts
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Contact: Hee Seung Kim, MD 82-2-2072-4863 bboddi0311@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seungmee Lee, MD    82-2-2072-2821    yumenoarika@naver.com   
Contact: Hee Seung Kim, MD    82-2-2072-4863    bboddi0311@gmail.com   
Principal Investigator: Hee Seung Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee Seung Kim, MD Seoul National University Hospital

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Responsible Party: Hee Seung Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02986568     History of Changes
Other Study ID Numbers: 2015-1616
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hee Seung Kim, Seoul National University Hospital:
Ontogenetic surgery
TMMR
PMMR
LEER

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Doxorubicin
Liposomal doxorubicin
Fluorouracil
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs