Unique ID issued by UMIN | UMIN000019081 |
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Receipt number | R000022059 |
Scientific Title | A phase I/II study of hybrid brachytherapy for locally advanced cervical carcinoma |
Date of disclosure of the study information | 2015/09/30 |
Last modified on | 2022/07/15 05:37:57 |
A phase I/II study of hybrid brachytherapy for locally advanced cervical carcinoma
Cervical cancer- Hybrid brachytherapy
A phase I/II study of hybrid brachytherapy for locally advanced cervical carcinoma
Cervical cancer- Hybrid brachytherapy
Japan |
Cervical cancer
Obstetrics and Gynecology | Radiology |
Malignancy
NO
A phase I, II study evaluating safety and efficacy of hybrid brachytherapy for locally advanced cervical carcinoma
Safety,Efficacy
Exploratory
Phase I,II
Phase I part:
Rate of acute non-hematologic toxicity greater than grade 3 which is obviously attributed to hybrid brachytherapy
Phase II part:
2-year pelvic relapse-free survival
Phase I part:
Pelvic relapse-free survival, overall survival, progression-free survival
Phase II part: dose constraint adherence rate of HBT, 2-year overall survival, 2-year progression-free survival, 2-year metastasis-free survival, the rate of acute toxicity, the rate of late toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
External beam irradiation, Chemotherapy, Hybrid intracavitary/interstitial brachytherapy
Patient enrollment period: 8 months after permission of the clinical trial for phase I study, 3 months intermittent pause of enrollment after 20 patients registration, 1 year and 1 months
Follow-up period: 2 years after finish of patients enrollment
Extarnal beam irradiation: whole pelvis irradiation (30Gy/15fr or 30.6Gy/17fr) + central shield (20Gy/10fr or 19.8Gy/11fr)
Systemic chemotherapy: weekly CDDP (40mg/m2)
Hybrid intracavitary/interstitial brachytherapy: starts after the initiation of central shiled, 24Gy/4fr
20 | years-old | <= |
75 | years-old | >= |
Female
Primary registration
1) Pathologically proven squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix
2) Age between 20 and 75 years old
3) FIGO stage IB2, IIA2, IIB, IIIA, IIIB, IVA(bladder invasion)
4) Patients for whom primary radiation therapy is planned
5) Tumor width greater than 5 cm assessed by pretreatment image examination
6) ECOG (Zubrod) performance status 0-2
7) No prior radiation therapy, chemotherapy, nor surgery for cervical cancer
8) Patients with sufficient organ function
- neutrophil count greater than 2,000/mm3
- hemoglobin greater than 8g/dL
- platelets greater than 50,000/mm3
- total bilirubin lower than 1.5mg/dL
- AST (GOT) and ALT (GPT) lower than 100 IU/L
-serum creatinine lower than 1.2mg/dL
-creatinine clearance higher than 60mL/min
9) It is possible to stop taking or do not intake any anticoagulant or antiplatelet
10) No prior chemotherapy or no prior abdominopelvic irradiation
11) Patient must provide study-specific informed consent prior to study entry
Secondary registration
1) Primary registration was already done
2) Tumor width greater than 4 cm assessed by pre-HBT image examination
3) ECOG (Zubrod) performance status 0-2
4) Neutrophil greater than 2,000/mm3 and platelet greater than 50,000/mm3
Primary registration
1) Patients with para-aortic lymph node metastasis.
2) Uncontrollable diabetes mellitus
3) Uncontrollable hypertension
4) Unstable angina pectoris or transmural myocardial infarction within the last 6 months
5) Prior invasive malignancy unless disease free for a minimum of 5 years. For example, carcinoma in situ of the breast, oral cavity, or esophagus are all permissible.
6) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
7) Body temperature greater than 38 degree Celsicus
8) Psychiatric comorbidities or problems hinders enrollment of the study
9) Active ulcerative colitis or Crohn's disease
10) Active systemic lupus erythematosus or scleroderma
11) Allergy to local anesthesia
12) Attending physician believes the patient is not suitable for the study
13) Positive for hepatitis B Surface antigen
Secondary registration
1) Patients with FIGO IIIA and after 30/30.6 Gy of pelvic irradiation, still depth of the vaginal invasion exceeds 5 mm and cannot be handled with intracavitary brachytherapy
2) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
3) Body temperature greater than 38 degree Celsicus
55
1st name | Jun |
Middle name | |
Last name | Itami |
National Cancer Center Hospital
Department of Radiation Oncology
104-0045
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
03-3542-2511
namuraka@ncc.go.jp
1st name | Naoya |
Middle name | |
Last name | Murakami |
National Cancer Center Hospital
Department of Radiation Oncology
104-0045
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
03-3542-2511
namuraka@ncc.go.jp
National Cancer Center Hospital, Department of Radiation Oncology
Japan Agency for Medical Research and development
Japanese Governmental office
Japan
National Cancer Center Hospital, Support Center
Tsukiji Chuo-ku 5-1-1
03-3542-2511
CRL_office@ml.res.ncc.go.jp
NO
国立研究開発法人国立がん研究センター中央病院(東京都)
東北大学病院(宮城県)
山形大学医学部附属病院(山形県)
群馬大学医学部附属病院(群馬県)
群馬県立がんセンター(群馬県)
筑波大学附属病院(茨城県)
埼玉医科大学国際医療センター(埼玉県)
東京医科歯科大学医学部附属病院(東京都)
がん研有明病院(東京都)
千葉大学医学部附属病院(千葉県)
国立研究開発法人放射線医学総合研究所重粒子医科学センター病院(千葉県)
大阪医科大学附属病院(大阪府)
大阪大学医学部附属病院(大阪府)
独立行政法人国立病院機構大阪医療センター(大阪府)
神戸大学医学部附属病院(兵庫県)
京都府立医科大学附属病院(京都府)
兵庫県立がんセンター(兵庫県)
川崎医科大学付属病院(岡山県)
香川県立中央病院(香川県)
徳島大学病院(徳島県)
高知大学医学部附属病院(高知県)
独立行政法人国立病院機構福山医療センター(広島県)
九州大学病院(福岡県)
独立行政法人国立病院機構九州がんセンター(福岡県)
日本私立学校振興・共済事業団 東京臨海病院(東京都)
東京都立墨東病院(東京都)
トヨタ記念病院(愛知県)
順天堂大学医学部附属浦安病院(千葉県)
National Cancer Center Hospital, Tokyo
Tohoku University Hospital, Miyagi
Yamagata University Hospital, Yamagata
Gunma University Hospital, Gunma
Gunma Prefectural Cancer Center, Gunma
University of Tsukuba Hospital, Ibaraki
Saitama Medical University International Medical Center, Saitama
Medical Hospital, Tokyo Medical and Dental University, Tokyo
Cancer Institute Hospital, Tokyo
Chiba University Hospital, Chiba
Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba
Osaka Medical College Hospital, Osaka
Osaka University Hospital, Osaka
National Hospital Organization Osaka National Hospital, Osaka
Kobe University Hospital, Hyogo
University Hospital, Kyoto Prefectural University of Medicine, Kyoto
Hyogo Cancer Center, Hyogo
Kawasaki Medical School Hospital, Okayama
Kagawa Prefectural Central Hospital, Kagawa
Tokushima University Hospital, Tokushima
Kochi Medical School Hospital, Kochi
National Hospital Organization Fukuyama Medical Center, Hiroshima
Kyushu University Hospital, Fukuoka
National Hospital Organization Kyushu Cancer Center, Fukuoka
Tokyo Rinkai Hospital, Tokyo
Tokyo Metropolitan Bokutoh Hospital, Tokyo
Toyota Memorial Hospital, Aichi
Juntendo University Urayasu Hospital, Chiba
2015 | Year | 09 | Month | 30 | Day |
Partially published
https://doi.org/10.1093/jjco/hyac072
52
The lower range of 90% CI of 2-year PPFS was 69.7% was higher than the historical control, therefore, the primary endpoint of this study was met and it can be said that HBT is superior to conventional ICBT in terms of local control based on a prospective clinical trial. In addition, the primary endpoint of phase I part of this study was the rate of acute non-hematologic adverse events related to HBT lower than 10% and it was shown that it was < 10% and feasibility of HBT was demonstrated with this study.
2022 | Year | 07 | Month | 15 | Day |
BetweenOctober2015andOctober2019,74patientsunderwentprimaryregistration,with52patientseventuallyproceedingtothesecondaryregistration.Themedianpretreatmenttumorwidthwas5.7cm,andFIGOStageswereIB210,IIA22,IIB20andIIIB20,respectively.
Patient accrual was slower than the initially expected period of two years, and although the total accrual number was fewer than the initially intended number of 55, it was decided that further prolongation of patient accrual was inappropriate, patient accrual was stopped when the total patient number exceeded 50. When the 20th patient proceeded to the secondary registration, patient accrual was temporarily stopped to see whether grade 3 or higher acute non-hematological adverse events related to the hybrid of intracavitary and interstitial brachytherapy (HBT) was lower than 10%. Because it was lower than 10%, the clinical study proceeded to the phase II part. All patients completed the planned protocol treatment, and late severe adverse events related to the protocol treatment were within what was initially expected.
Late grade 3 or higher non-hematologic adverse events were observed in three patients (5.8%) and one grade 4 event was observed only in one patient (1.9%, uterine bleeding). No grade 5 adverse event was observed.
No longer recruiting
2015 | Year | 07 | Month | 19 | Day |
2015 | Year | 07 | Month | 28 | Day |
2015 | Year | 10 | Month | 01 | Day |
2021 | Year | 11 | Month | 01 | Day |
2022 | Year | 04 | Month | 14 | Day |
2022 | Year | 04 | Month | 14 | Day |
2022 | Year | 04 | Month | 14 | Day |
2015 | Year | 09 | Month | 20 | Day |
2022 | Year | 07 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022059
Research Plan | |
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Registered date | File name |
2017/09/24 | HBTプロトコール 17版.docx |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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