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Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT01461746
Recruitment Status : Unknown
Verified May 2017 by Joo-Hyun Nam, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : October 28, 2011
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center

Study Description
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Brief Summary:
Previous some studies suggested the addition of chemotherapy to radiation therapy after surgery may have survival benefit in patients with high risk endometrial cancer. In addition, docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin which is currently used in most cases. However, docetaxel plus cisplatin may cause less toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators aimed to analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after surgery in patients with high risk endometrial cancer.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: Docetaxel Drug: Cisplatin Radiation: Radiation therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery
Study Start Date : October 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Chemotherpay and radiation therapy
Docetaxel plus cisplatin followed by radiation therapy
 Drug: Docetaxel
Docetaxel 70mg/m2BSA, q 3 weeks, 3 cycles

Drug: Cisplatin
Cisplatin 60mg/m2BSA, q 3 weeks, 3 cycles

Radiation: Radiation therapy
Pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years after completion of study treatment ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years after completion of study treatment ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Before each chemotherapy, an expected average of 3 weeks ]
  3. Quality of life [ Time Frame: 3 months after completion of study treatment ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • One of following high risk groups Stage III after staging operation Stage II (Type I hysterectomy + BSO + LND) Stage I + two of [Grade III, LVSI+, Mm>1/2] Clear cell or serous carcinoma: stage IB-II
  • Age: 20-75
  • ECOG PS: 0-2
  • Adequate organ function BM: WBC ≥ 3,000/mm3, ANC≥1,500/mm3, Plt≥100X103/mm3, Hb≥10.0 g/dl Kidney: Creatinine <1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3
  • Informed Consent

Exclusion Criteria:

  • Previous chemotherapy or pelvic RT
  • Hormone therapy within 4 weeks
  • Other malignant disease
  • Uncontrolled medical disease
  • Infection requiring antibiotics
  • Symptomatic CHF, RF, Angina, Arrhythmia, etc.
  • Neurosis or psychosis
  • Etc.
Contacts and Locations
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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): NCT01461746


Contacts
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Contact: Joo-Hyun Nam, M.D., Ph.D. +82-10-3010-3633 jhnam@amc.seoul.kr
Contact: Jeong-Yeol Park, M.D., Ph.D. +82-10-3010-3646 obgyjypark@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo-Hyun Nam, M.D., Ph.D.    +82-2-3010-3633    jhnam@amc.seoul.kr   
Contact: Jeong-Yeol Park, M.D., Ph.D.    +82-2-3010-3646    obgyjypark@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Boryung Pharmaceutical Co., Ltd
Investigators
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Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
More Information
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Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01461746    
Other Study ID Numbers: ANSGOG-001
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
 Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action