UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004550 |
|---|---|
| Receipt number | R000005436 |
| Scientific Title | RANDOMIZED PHASE III CLINICAL TRIAL OF ADJUVANT RADIATION VERSUS CHEMORADIATION IN INTERMEDIATE RISK, STAGE I/IIA CERVICAL CANCER TREATED WITH INITIAL RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY |
| Date of disclosure of the study information | 2010/11/12 |
| Last modified on | 2024/09/29 18:56:12 |
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Basic information
Public title
RANDOMIZED PHASE III CLINICAL TRIAL OF ADJUVANT RADIATION VERSUS CHEMORADIATION IN INTERMEDIATE RISK, STAGE I/IIA CERVICAL CANCER TREATED WITH INITIAL RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY
Acronym
GOG-0263
Scientific Title
RANDOMIZED PHASE III CLINICAL TRIAL OF ADJUVANT RADIATION VERSUS CHEMORADIATION IN INTERMEDIATE RISK, STAGE I/IIA CERVICAL CANCER TREATED WITH INITIAL RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY
Scientific Title:Acronym
GOG-0263
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
INTERMEDIATE RISK, STAGE I/IIA CERVICAL CANCER TREATED WITH INITIAL RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1)To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in Stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy.
2)To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in Stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy.
Basic objectives2
Others
Basic objectives -Others
1)To assess differences (across treatment arms) in incidence and severity of therapy attributed adverse events
utilizing the active version of CTCAE.
2)To determine whether post-operative adjuvant CRT improves the health related Quality of Life (QOL) (compared to RT alone) as measured by FACT-Cx TOI and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
recurrence-free survival
Key secondary outcomes
overall survival, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
radiation therapy( External pelvic standard radiation or IMRT )
Interventions/Control_2
Cisplatine 40mg/m2(max=70mg)IV over 1-2 hours weekly 6cycles with radiation therapy( External pelvic standard radiation or IMRT )
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients with Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy.
2) Patients with the following characteristics ( depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed ) :
2-1) Patients with Positive capillary-lymphovascular space involvement and one of the following :
- Deep third penetration
- Middle third penetration, clinical tumor >=2cm
- Superficial third penetration, clinical tumor >=5cm
2-2) Patients with Negative capillary-lymphatic space involvement :
- Middle or deep third penetration, clinical tumor >= 4cm
3) Patients must have adequate :
- Hematologic function : ANC>= 1,500/mcl, platelets >= 100,000/mcl
- Renal function : creatinine<= ULN or calculated creatinine clearance>=60 mL/min
- Hepatic function : bilirubin <= 1.5 x normal, alkaline phosphate and SGOT <= 3 x normal
4) Patients with GOG performance status 0,1,2.
5) Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery.
6) Patients who have met the pre-entry requirements specified in Section 7.0.
7) Patients must have signed an approved informed consent and authorization permitting release of personal health information.
Key exclusion criteria
1) Patients with tumor in the parametria, pelvic lymph nodes or any other extra
uterine site or with positive surgical margins.
2) Patients with septicemia or severe infection.
3) Patients with intestinal obstruction or gastrointestinal bleeding.
4) Patients with postoperative fistula.
5) Patients with cervix cancer who have received any previous radiation or chemotherapy.
6) Patients whose circumstances do not permit completion of the study or the
required follow-up.
7) Patients with renal abnormalities requiring modification of radiation field
(pelvic kidney, renal transplant, etc).
8) Patients with GOG Performance Status of 3 or 4.
9) Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SANG YOUNG RYU |
Organization
Korea Cancer Center
Division name
Department of Gynecologic Oncology
Zip code
Address
215-4 GONGNEUNG-DONG, NOWAN-GU, SEOUL, KOREA, 139-709
TEL
82-2-970-1227
ryu@kcch.re.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadao Takano, MD. |
Organization
Tohoku University School of Medicine
Division name
Department of Gynecology
Zip code
Address
1-1 Seiryo-Machi, Aoba-ku
TEL
022-717-7000
Homepage URL
http://www.gog.org
ttakano@med.tohoku.ac.jp
Sponsor or person
Institute
NRG Oncology
Institute
Department
Personal name
Funding Source
Organization
NRG Oncology
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岩手医科大学附属病院（岩手県）、東北大学病院（宮城県）、国立がん研究センター中央病院（東京都）、近畿大学医学部附属病院（大阪府）、四国がんセンター（愛媛県）、呉医療センター・中国がんセンター（広島県）、鹿児島市立病院（鹿児島県）、新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005436
