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Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer (JCOG1801)

Primary Purpose

Rectal Cancer Recurrent

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Chemotherapy
Preoperative radiotherapy
Procedure
Sponsored by
National Cancer Center Hospital East
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer Recurrent focused on measuring Rectal cancer, Locally recurrent rectal cancer, Chemoradiotherapy, Surgery, Chemotherapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer.
  2. The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal canal.
  3. Either of the following treatments was performed for the initial rectal cancer, and classified as R0/1 or ER (Endoscopical R)0/1 on pathological diagnosis.

    i) Surgical resection (including local resection, with or without lymph node dissection).

    ii) Endoscopic resection.

  4. Patients with distant metastasis during or after treatment for the initial rectal cancer, and radical surgical resection or radical radiotherapy performed more than 168 days before registration is eligible.
  5. Recurrent rectal cancer diagnosed by any of the following modalities after treatment for the initial rectal cancer.

    i) The recurrent lesion is pathologically diagnosed. ii) Diagnosed as local recurrence by more than two modalities among contrast-enhanced CT, contrast-enhanced MRI, or positron emission computed tomography (PET).

    iii) Chronological progression of the lesion seen on more than one modality among contrast-enhanced CT, MRI, or PET.

  6. The main tumor location is within pelvis as seen on contrast-enhanced CT and MRI if recurrent lesion is multiple, or recurrent lesions spread outside of pelvis continuously.
  7. LRRC is diagnosed with no following condition. i) Judged as resectable endoscopically. ii) Depth of invasion within the muscularis propria as seen on contrast-enhanced CT, MRI, or PET in case of recurrence inside the intestine iii) Solitary ovarian metastasis. iv) Recurrence of the common iliac lymph node alone.
  8. LRRC is diagnosed as resectable, and all the following conditions must be fulfilled:

    i) No distant metastasis on contrast-enhanced CT (cM0). ii) Estimated circumferential resection margin >0 mm. iii) Leg amputation not required. iv) Preservation of the first sacral nerve possible.

  9. No prior surgery for recurrent rectal cancer.
  10. No prior pelvic irradiation for any malignancies.
  11. A patient who has received systemic chemotherapy for any malignancies and the final dose was administered more than 14 days ago.
  12. Age at registration is 20 to 80 years old.
  13. Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1.
  14. Measurable lesion is not mandatory.
  15. Adequate oral intake.
  16. Sufficient organ function. i) Neutrophil count >= 1,500/mm3 ii) Hemoglobin >= 9.0 g/dL iii) Platelet count >= 100,000/mm3 iv) Total Bilirubin =< 2.0 mg/dL v) Aspartate aminotransferase (AST) =< 100 U/L vi) Alanine Aminotransferase (ALT) =< 100 U/L vii) Cr =< 1.5 mg/dL
  17. Open surgery or laparoscopic surgery is planned.
  18. Written informed consent is obtained.

Exclusion Criteria:

  1. Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
  2. Infections requiring systemic treatment.
  3. Body temperature higher than 38 degrees Celsius at registration.
  4. Pregnant female, female within 28 days post-parturition, or lactating mother. Men with partners planning conception in the near future.
  5. Severe psychological disease.
  6. Continuous systemic corticosteroid or immunosuppressant treatment.
  7. Uncontrollable diabetes mellitus.
  8. Uncontrollable hypertension.
  9. Unstable angina pectoris, or history of myocardial infarction within 6 months.
  10. Uncontrollable valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
  11. Positive serum Hepatitis B (HB)s antigen or serum Hepatitis C Virus (HCV) antibody.
  12. Positive serum HIV antibody.
  13. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.

Sites / Locations

  • Chiba Cancer CenterRecruiting
  • Gifu University School of MedicineRecruiting
  • Saitama Medical University International Medical Center
  • Kansai Medical University Hospital
  • Hiroshima City Asa Citizens HospitalRecruiting
  • Hiroshima City HospitalRecruiting
  • Shimane University Faculty of MedicineRecruiting
  • Ishikawa Prefectural Central HospitalRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Saitama Medical Center, Saitama Medical UniversityRecruiting
  • Kochi Health Sciences CenterRecruiting
  • Kumamoto University HospitalRecruiting
  • Kurashiki Central HospitalRecruiting
  • Kurume University School of MedicineRecruiting
  • National Hospital Organization Shikoku Cancer CenterRecruiting
  • Kyorin University Faculty of MedicineRecruiting
  • Iwate Medical University
  • Nagoya University Graduate School of Medicine
  • Niigata Cancer Center HospitalRecruiting
  • Hyogo College of MedicineRecruiting
  • Okayama Saiseikai General HospitalRecruiting
  • National Hospital Organization Osaka National HospitalRecruiting
  • Osaka City General HospitalRecruiting
  • Saitama Cancer CenterRecruiting
  • Sapporo-Kosei General HospitalRecruiting
  • Miyagi Cancer CenterRecruiting
  • Shizuoka Cancer CenterRecruiting
  • Osaka University Graduate School of MedicineRecruiting
  • Suita Municipal HospitalRecruiting
  • Osaka Medical CollegeRecruiting
  • National Defense Medical CollegeRecruiting
  • National Cancer Center HospitalRecruiting
  • Toho University Ohashi Medical CenterRecruiting
  • Toho University Omori Medical Center
  • Tokyo Medical and Dental University HospitalRecruiting
  • Tokyo Medical University HospitalRecruiting
  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome HospitalRecruiting
  • Tochigi Cancer CenterRecruiting
  • Yamagata Prefectural Central HospitalRecruiting
  • Kanagawa Cancer CenterRecruiting
  • Saiseikai Yokohama-shi Nanbu HospitalRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Oita University Faculty of MedicineRecruiting
  • Ogaki Municipal HospitalRecruiting
  • Gunma Prefectural Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr) Adjuvant chemotherapy: CAPOX (capecitabine+oxaliplatin) or mFOLFOX6 (5-fluorouracil+l-leucovorin+oxaliplatin) or capecitabine or 5-fluorouracil (FU) +l-leucovorin (LV) CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours

Surgery plus Adjuvant chemotherapy Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours

Outcomes

Primary Outcome Measures

Locally recurrent free survival
the period from registration in the trial to either the first event of local relapse or death from any cause and censored at the last date of contact for a living patient

Secondary Outcome Measures

Overall survival (OS)
s the time from registration to death from any cause and censored at the last date of contact for a living patient
Recurrence free survival (RFS)
the time from registration to either the first incidence of relapse or death from any cause and censored at the last date of contact for a living patient
Local relapse rate
Proportion of local relapse
Distant relapse rate
Proportion of distant relapse
R0 resection rate
Proportion of patients with pathological R0 resection
Response rate of preoperative chemoradiotherapy (preCRT)
Response rate of preCRT (arm B)
Pathological complete response rate
Pathological complete response rate (arm B)
Completeness of the protocol treatment
Proportion of patients who completed the protocol treatment
Adverse event rate
Incidence of adverse events (adverse reactions)
QOL
QOL after surgery based on the Trial Outcome Index-Physical/Functional/Colorectal (TOI-PFC) [0(better)-84(worse)]

Full Information

First Posted
February 26, 2020
Last Updated
June 2, 2020
Sponsor
National Cancer Center Hospital East
Collaborators
Japan Clinical Oncology Group, Japan Agency for Medical Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04288999
Brief Title
Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
Acronym
JCOG1801
Official Title
JCOG1801: A Phase III Randomized Controlled Trial Comparing Surgery Plus Adjuvant Chemotherapy With Preoperative Chemoradiotherapy Followed by Surgery Plus Adjuvant Chemotherapy for Locally Recurrent Rectal Cancer (RC-SURVIVE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
October 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Center Hospital East
Collaborators
Japan Clinical Oncology Group, Japan Agency for Medical Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.
Detailed Description
In all, 110 patients from 43 Japanese institutions will be recruited over a period of 6 years. Eligible patients would be registered and randomly assigned to each group with an allocation ratio of 1:1. The primary endpoint is local relapse-free survival. The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions), and quality of life after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer Recurrent
Keywords
Rectal cancer, Locally recurrent rectal cancer, Chemoradiotherapy, Surgery, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr) Adjuvant chemotherapy: CAPOX (capecitabine+oxaliplatin) or mFOLFOX6 (5-fluorouracil+l-leucovorin+oxaliplatin) or capecitabine or 5-fluorouracil (FU) +l-leucovorin (LV) CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Surgery plus Adjuvant chemotherapy Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV
Intervention Description
Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours
Intervention Type
Radiation
Intervention Name(s)
Preoperative radiotherapy
Other Intervention Name(s)
Capecitabine plus radiotherapy
Intervention Description
Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)
Intervention Type
Other
Intervention Name(s)
Procedure
Other Intervention Name(s)
Surgery
Intervention Description
Surgery for Locally Recurrent Rectal Cancer (LRRC) will be performed within 42 days from registration for the patients in arm A, and between days 56 and 98 from the completion of the preCRT for the patients in arm B. Appropriate surgical procedure will be performed to achieve R0 resection, such as low anterior resection, super low anterior resection, intersphincteric resection, Hartmann procedure, rectal amputation, pelvic exenteration, tumor resection, or lateral lymph node dissection
Primary Outcome Measure Information:
Title
Locally recurrent free survival
Description
the period from registration in the trial to either the first event of local relapse or death from any cause and censored at the last date of contact for a living patient
Time Frame
3-years after registration
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
s the time from registration to death from any cause and censored at the last date of contact for a living patient
Time Frame
3-years after registration
Title
Recurrence free survival (RFS)
Description
the time from registration to either the first incidence of relapse or death from any cause and censored at the last date of contact for a living patient
Time Frame
3-years after registration
Title
Local relapse rate
Description
Proportion of local relapse
Time Frame
3-years after registration
Title
Distant relapse rate
Description
Proportion of distant relapse
Time Frame
3-years after registration
Title
R0 resection rate
Description
Proportion of patients with pathological R0 resection
Time Frame
1 month after surgery
Title
Response rate of preoperative chemoradiotherapy (preCRT)
Description
Response rate of preCRT (arm B)
Time Frame
before surgery
Title
Pathological complete response rate
Description
Pathological complete response rate (arm B)
Time Frame
1 month after surgery
Title
Completeness of the protocol treatment
Description
Proportion of patients who completed the protocol treatment
Time Frame
8 months after surgery
Title
Adverse event rate
Description
Incidence of adverse events (adverse reactions)
Time Frame
3-years after surgery registration
Title
QOL
Description
QOL after surgery based on the Trial Outcome Index-Physical/Functional/Colorectal (TOI-PFC) [0(better)-84(worse)]
Time Frame
3-years after registration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer. The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal canal. Either of the following treatments was performed for the initial rectal cancer, and classified as R0/1 or ER (Endoscopical R)0/1 on pathological diagnosis. i) Surgical resection (including local resection, with or without lymph node dissection). ii) Endoscopic resection. Patients with distant metastasis during or after treatment for the initial rectal cancer, and radical surgical resection or radical radiotherapy performed more than 168 days before registration is eligible. Recurrent rectal cancer diagnosed by any of the following modalities after treatment for the initial rectal cancer. i) The recurrent lesion is pathologically diagnosed. ii) Diagnosed as local recurrence by more than two modalities among contrast-enhanced CT, contrast-enhanced MRI, or positron emission computed tomography (PET). iii) Chronological progression of the lesion seen on more than one modality among contrast-enhanced CT, MRI, or PET. The main tumor location is within pelvis as seen on contrast-enhanced CT and MRI if recurrent lesion is multiple, or recurrent lesions spread outside of pelvis continuously. LRRC is diagnosed with no following condition. i) Judged as resectable endoscopically. ii) Depth of invasion within the muscularis propria as seen on contrast-enhanced CT, MRI, or PET in case of recurrence inside the intestine iii) Solitary ovarian metastasis. iv) Recurrence of the common iliac lymph node alone. LRRC is diagnosed as resectable, and all the following conditions must be fulfilled: i) No distant metastasis on contrast-enhanced CT (cM0). ii) Estimated circumferential resection margin >0 mm. iii) Leg amputation not required. iv) Preservation of the first sacral nerve possible. No prior surgery for recurrent rectal cancer. No prior pelvic irradiation for any malignancies. A patient who has received systemic chemotherapy for any malignancies and the final dose was administered more than 14 days ago. Age at registration is 20 to 80 years old. Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1. Measurable lesion is not mandatory. Adequate oral intake. Sufficient organ function. i) Neutrophil count >= 1,500/mm3 ii) Hemoglobin >= 9.0 g/dL iii) Platelet count >= 100,000/mm3 iv) Total Bilirubin =< 2.0 mg/dL v) Aspartate aminotransferase (AST) =< 100 U/L vi) Alanine Aminotransferase (ALT) =< 100 U/L vii) Cr =< 1.5 mg/dL Open surgery or laparoscopic surgery is planned. Written informed consent is obtained. Exclusion Criteria: Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers. Infections requiring systemic treatment. Body temperature higher than 38 degrees Celsius at registration. Pregnant female, female within 28 days post-parturition, or lactating mother. Men with partners planning conception in the near future. Severe psychological disease. Continuous systemic corticosteroid or immunosuppressant treatment. Uncontrollable diabetes mellitus. Uncontrollable hypertension. Unstable angina pectoris, or history of myocardial infarction within 6 months. Uncontrollable valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. Positive serum Hepatitis B (HB)s antigen or serum Hepatitis C Virus (HCV) antibody. Positive serum HIV antibody. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuichiro Tsukada, MD,PhD
Phone
+80-4-7133-1111
Email
yutsukad@east.ncc.go.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Masaaki Ito, MD, PhD
Phone
+80-4-7133-1111
Email
maito@east.ncc.go.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaaki Ito, MD, PhD
Organizational Affiliation
National Cancer Center Hospital East
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiba Cancer Center
City
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuhiro Takiguchi
Facility Name
Gifu University School of Medicine
City
Gifu
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuhiro Yoshida
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeki Yamaguchi
Facility Name
Kansai Medical University Hospital
City
Hirakata
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitsugu Sekimoto
Facility Name
Hiroshima City Asa Citizens Hospital
City
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mamoru Shimomura
Facility Name
Hiroshima City Hospital
City
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masazumi Okajima
Facility Name
Shimane University Faculty of Medicine
City
Izumo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshitsugu Tajima
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroyuki Bando
Facility Name
National Cancer Center Hospital East
City
Kashiwa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaaki Ito
Facility Name
Saitama Medical Center, Saitama Medical University
City
Kawagoe
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideyuki Ishida
Facility Name
Kochi Health Sciences Center
City
Kochi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryo Inada
Facility Name
Kumamoto University Hospital
City
Kumamoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideo Baba
Facility Name
Kurashiki Central Hospital
City
Kurashiki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuyuki Kawamoto
Facility Name
Kurume University School of Medicine
City
Kurume
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshito Akagi
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takaya Kobatake
Facility Name
Kyorin University Faculty of Medicine
City
Mitaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tadahiko Masaki
Facility Name
Iwate Medical University
City
Morioka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koki Otsuka
Facility Name
Nagoya University Graduate School of Medicine
City
Nagoya
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keisuke Uehara
Facility Name
Niigata Cancer Center Hospital
City
Niigata
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasumasa Takii
Facility Name
Hyogo College of Medicine
City
Nishinomiya
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naohiro Tomita
Facility Name
Okayama Saiseikai General Hospital
City
Okayama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihiro Akazai
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takeshi Kato
Facility Name
Osaka City General Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Maeda
Facility Name
Saitama Cancer Center
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusuke Nishizawa
Facility Name
Sapporo-Kosei General Hospital
City
Sapporo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideki Yamagami
Facility Name
Miyagi Cancer Center
City
Sendai
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kou Miura
Facility Name
Shizuoka Cancer Center
City
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akio Shiomi
Facility Name
Osaka University Graduate School of Medicine
City
Suita
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsunekazu Mizushima
Facility Name
Suita Municipal Hospital
City
Suita
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Okamura
Facility Name
Osaka Medical College
City
Takatsuki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junji Okuda
Facility Name
National Defense Medical College
City
Tokorozawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideki Ueno
Facility Name
National Cancer Center Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukihide Kanemitsu
Facility Name
Toho University Ohashi Medical Center
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihisa Saida
Facility Name
Toho University Omori Medical Center
City
Tokyo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimihiko Funahashi
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusuke Kinugasa
Facility Name
Tokyo Medical University Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akihiko Tsuchida
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keiichi Takahashi
Facility Name
Tochigi Cancer Center
City
Utsunomiya
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shin Fujita
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshihiko Sato
Facility Name
Kanagawa Cancer Center
City
Yokohama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manabu Shiozawa
Facility Name
Saiseikai Yokohama-shi Nanbu Hospital
City
Yokohama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tadao Fukushima
Facility Name
Yokohama City University Medical Center
City
Yokohama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Watanabe
Facility Name
Oita University Faculty of Medicine
City
Yufu
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masafumi Inomata
Facility Name
Ogaki Municipal Hospital
City
Ōgaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichi Takayama
Facility Name
Gunma Prefectural Cancer Center
City
Ōta
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hitoshi Ojima

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32409830
Citation
Kadota T, Tsukada Y, Ito M, Katayama H, Mizusawa J, Nakamura N, Ito Y, Bando H, Ando M, Onaya H, Fukuda H, Kanemitsu Y. A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancer: Japan Clinical Oncology Group study JCOG1801 (RC-SURVIVE study). Jpn J Clin Oncol. 2020 Aug 4;50(8):953-957. doi: 10.1093/jjco/hyaa058.
Results Reference
derived
Links:
URL
https://jrct.niph.go.jp/en-latest-detail/jRCTs031190076
Description
Japan Registry of Clinical Trials

Learn more about this trial

Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer

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