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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017603
Receipt No. 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 2015/05/18

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Basic information
Public 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)
Acronym 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)
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)
Scientific Title:Acronym 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)
Region
Japan

Condition
Condition Lower rectal cancer with suspected lateral pelvic node metastasis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Phase II: Proportion of patients with R0 resection, Phase III: Overall survival
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 A: T(S)ME+LND and postoperative chemotherapy (mFOLFOX 12 cycles)
Interventions/Control_2 B: preoperative chemotherapy (mFOLFOX 6 cycles), T(S)ME+LND, and postoperative chemotherapy (mFOLFOX 6 cycles)
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
20 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro shimada
Organization Kochi Health Sciences Center, Kochi
Division name Department of Gastrointestinal Medical Oncology Division
Zip code
Address 2125-1 Ike, Kochi-City, Kochi, Japan, 781-8555
TEL 088-837-3000
Email yasuhiro_shimada@khsc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Ohue, Satoru Iwasa
Organization JCOG1310 Coordinating Office
Division name (1)Osaka Medical Center for Cancer & Cardiovascular Diseases (2)National Cancer Center Hospital
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku,Osaka, Japan, 537-8511/5-1-1,Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
TEL (1)06-6879-3251(2)03-3542-2511
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 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)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 18 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 18 Day
Last follow-up date
2028 Year 05 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 18 Day
Last modified on
2015 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020353

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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