Unique ID issued by UMIN | UMIN000017603 |
---|---|
Receipt number | R000020353 |
Scientific Title | A phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis (JCOG1310, PRECIOUS trial) |
Date of disclosure of the study information | 2015/05/18 |
Last modified on | 2021/01/05 18:51:13 |
A phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis (JCOG1310, PRECIOUS trial)
A phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis (JCOG1310, PRECIOUS trial)
A phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis (JCOG1310, PRECIOUS trial)
A phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis (JCOG1310, PRECIOUS trial)
Japan |
Lower rectal cancer with suspected lateral pelvic node metastasis
Gastrointestinal surgery |
Malignancy
NO
To evaluate the survival benefit and safety of perioperative mFOLFOX6 compared to postoperative mFOLFOX6 in lower lectal cancer with susupected lateral lymph node metastasis in a randomized phase II/III trial.
Safety,Efficacy
Confirmatory
Phase II,III
Phase II: Proportion of patients with R0 resection, Phase III: Overall survival
Phase II part: Proportion of operative complication, Proportion of patients who complete 12 cycles of chemotherapy
Phase III part: Progression-free survival, Local progression-free survival, Proportion of patients with R0 resection, Overall response rate of preoperative chemotherapy (Group B), Pathological complete response rate (Group B), Proportion of patients who complete 12 cycles of chemotherapy, Incidence of adverse events, Incidence of serious adverse events, Proportion of operative complication, Proportion of preservation of adjacent organs, Proportion of anus-preservation, Proportion of anus-preservation without stoma
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine | Maneuver |
A: T(S)ME+LND and postoperative chemotherapy (mFOLFOX 12 cycles)
B: preoperative chemotherapy (mFOLFOX 6 cycles), T(S)ME+LND, and postoperative chemotherapy (mFOLFOX 6 cycles)
20 | years-old | <= |
74 | years-old | >= |
Male and Female
1. Pathologically proven adenocarcinoma or adenosquamous carcinoma
2. Primary tumor located at Upper rectum, Lower rectum, and Anal canal
3. The lower border of the tumor located between the peritoneal reflection and the anal verge
4. cT2, cT3, and cT4 tumor on contrast-enhanced CT or MRI, except T4b tumor invading the trigone of bladder, urethra, or sacrum
5. Lateral lymph nodes with 10mm or more in short axis diameter on contrast-enhanced CT or MRI data of 5mm-thickness slices (cN3)
6. No distant metastasis on contrast-enhanced CT or MRI (cM0)
7. Aged 20 to 74 years old
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. No prior chemotherapy or treatment such as rectal resection, pelvic lymph node dissection, or pelvic irradiation for any malignancies
10. No other colorectal carcinoma, except cTis or cT1a
11. Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment
1) Neutrophil count >= 1,500 /mm3
2) Platelet count >= 100,000 /mm3
3) T.Bil =< 2.0 mg/dL
4) AST =< 100 IU/L
5) ALT =< 100 IU/L
6) Cr =< 1.5 mg/dL
12. Open surgery will be performed
13. Written informed consent
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
2) Infectious disease to be treated
3) Positive for HBs antigen
4) Body temperature >= 38 degrees Celsius
5) Women during pregnancy, possible pregnancy or breast-feeding
6) Severe mental disease
7) Currently treated with systemic steroids or immunosuppressive agents
8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT
9) Uncontrollable diabetes mellitus or routine administration of insulin
10) Unstable angina pectoris or previous myocardial infarction within the past 6 months
330
1st name | |
Middle name | |
Last name | Yasuhiro shimada |
Kochi Health Sciences Center, Kochi
Department of Gastrointestinal Medical Oncology Division
2125-1 Ike, Kochi-City, Kochi, Japan, 781-8555
088-837-3000
yasuhiro_shimada@khsc.or.jp
1st name | |
Middle name | |
Last name | Masayuki Ohue, Satoru Iwasa |
JCOG1310 Coordinating Office
(1)Osaka Medical Center for Cancer & Cardiovascular Diseases (2)National Cancer Center Hospital
1-3-3 Nakamichi, Higashinari-ku,Osaka, Japan, 537-8511/5-1-1,Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
(1)06-6879-3251(2)03-3542-2511
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group (JCOG)
Japan Agency for Medical Research and Development
Other
Japan
NO
札幌厚生病院(北海道)
岩手医科大学(岩手県)
宮城県立がんセンター(宮城県)
栃木県立がんセンター(栃木県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
東京医科大学病院(東京都)
がん・感染症センター都立駒込病院(東京都)
慶應義塾大学病院(東京都)
東京医科歯科大学(東京都)
東邦大学医療センター大橋病院(東京都)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
北里大学医学部(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
平塚市民病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟県厚生連長岡中央綜合病院(新潟県)
長野市民病院(長野県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
国立病院機構京都医療センター(京都府)
大阪大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪府立病院機構大阪府立急性期・総合医療センター(大阪府)
大阪医科大学(大阪府)
市立堺病院(大阪府)
箕面市立病院(大阪府)
市立吹田市民病院(大阪府)
関西労災病院(兵庫県)
兵庫医科大学(兵庫県)
医療法人薫風会佐野病院(兵庫県)
岡山済生会総合病院(岡山県)
広島市立広島市民病院(広島県)
県立広島病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
熊本大学医学部(熊本県)
大分大学医学部附属病院(大分県)
2015 | Year | 05 | Month | 18 | Day |
Unpublished
Completed
2015 | Year | 03 | Month | 24 | Day |
2015 | Year | 04 | Month | 23 | Day |
2015 | Year | 05 | Month | 18 | Day |
2028 | Year | 05 | Month | 18 | Day |
2020 | Year | 02 | Month | 20 | Day |
2015 | Year | 05 | Month | 18 | Day |
2021 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020353