Intensity-modulated Radiotherapy Protocol in Cervix Cancer
NCT ID: NCT02993653
Last Updated: 2016-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2015-01-31
2018-06-30
Brief Summary
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Detailed Description
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1. intensity-modulated radiotherapy of whole pelvis: 60 Gy in 30 fx Re-simulation with pelvic Magnetic resonance imaging at 46 Gy in 23 fx and intensity-modulated radiotherapy on the gross cervical and nodal tumor (initially Positron emission tomography-positive), 14 Gy in 7 fx
2. intensity-modulated radiotherapy boost of gross cervical tumor or Intra-cavitary radiotherapy (ICR)
* Re-staging pelvic Magnetic resonance imaging , if complete response occurs Intra-cavitary radiotherapy to A point, 25 Gy in 5 fx for 2 weeks
* Re-staging pelvic Magnetic resonance imaging I, partial response or stable disease occurs intensity-modulated radiotherapy boost , 10 Gy in 4 fx to the gross cervical tumor for 1 week
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intensity-modulated radiotheapy arm
Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy
High-dose Intensity-modulated radiotherapy
Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy
Interventions
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High-dose Intensity-modulated radiotherapy
Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy
Eligibility Criteria
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Inclusion Criteria
2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1
3. Patients with adequate bone marrow function: Absolute nutrophil count (ANC) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning
4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg/mL
5. Patients who have signed an approved informed consent and authorization
Exclusion Criteria
2. Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer
3. Patients with metastatic lymphadenopathies other than pelvis (e.g. inguinal, paraaortic, supraclavicular, or mediastinal node)
4. Patients with distant organ metastasis
18 Years
75 Years
ALL
Yes
Sponsors
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Seoul St. Mary's Hospital
OTHER
Responsible Party
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Jong Hoon Lee
Professor
Principal Investigators
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Jong Hoon Lee, MD
Role: PRINCIPAL_INVESTIGATOR
St. Vincent's Hospital, South Korea
Locations
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Lee Jong Hoon
Suwon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jong Hoon Lee
Role: primary
References
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Kang HB, Kim SH, Lee JH, Lee HC, Kang NK, Lee JH. MRI-based volumetric tumor parameters before and during chemoradiation predict tumor recurrence and patient survival in locally advanced cervical cancer: a subgroup analysis of a phase II prospective trial. Int J Clin Oncol. 2024 May;29(5):620-628. doi: 10.1007/s10147-024-02490-7. Epub 2024 Mar 26.
Lee HC, Jeong JW, Lee JH, Kim SH, Park DC, Yoon JH, Kim SI, Lee JH. High-dose (60 Gy) intensity-modulated radiotherapy with concurrent weekly cisplatin followed by intracavitary radiation in locally advanced cervical cancer: A phase II prospective clinical trial. Gynecol Oncol. 2023 Oct;177:142-149. doi: 10.1016/j.ygyno.2023.08.018. Epub 2023 Sep 7.
Other Identifiers
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VINPI1501
Identifier Type: -
Identifier Source: org_study_id