Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
JCOG1801
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)
1 other identifier
interventional
110
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2019
Longer than P75 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
ExpectedJune 4, 2020
June 1, 2020
5.8 years
February 26, 2020
June 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3-years after registration
Secondary Outcomes (10)
Overall survival (OS)
3-years after registration
Recurrence free survival (RFS)
3-years after registration
Local relapse rate
3-years after registration
Distant relapse rate
3-years after registration
R0 resection rate
1 month after surgery
- +5 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALPreoperative 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 B
ACTIVE COMPARATORSurgery 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
Interventions
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
Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)
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
Eligibility Criteria
You may qualify if:
- 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.
- +8 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Chiba Cancer Center
Chiba, Japan
Gifu University School of Medicine
Gifu, Japan
Saitama Medical University International Medical Center
Hidaka, Japan
Kansai Medical University Hospital
Hirakata, Japan
Hiroshima City Asa Citizens Hospital
Hiroshima, Japan
Hiroshima City Hospital
Hiroshima, Japan
Shimane University Faculty of Medicine
Izumo, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Japan
National Cancer Center Hospital East
Kashiwa, Japan
Saitama Medical Center, Saitama Medical University
Kawagoe, Japan
Kochi Health Sciences Center
Kochi, Japan
Kumamoto University Hospital
Kumamoto, Japan
Kurashiki Central Hospital
Kurashiki, Japan
Kurume University School of Medicine
Kurume, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Kyorin University Faculty of Medicine
Mitaka, Japan
Iwate Medical University
Morioka, Japan
Nagoya University Graduate School of Medicine
Nagoya, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Hyogo College of Medicine
Nishinomiya, Japan
Okayama Saiseikai General Hospital
Okayama, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Osaka City General Hospital
Osaka, Japan
Ogaki Municipal Hospital
Ōgaki, Japan
Gunma Prefectural Cancer Center
Ōta-ku, Japan
Saitama Cancer Center
Saitama, Japan
Sapporo-Kosei General Hospital
Sapporo, Japan
Miyagi Cancer Center
Sendai, Japan
Shizuoka Cancer Center
Shizuoka, Japan
Osaka University Graduate School of Medicine
Suita, Japan
Suita Municipal Hospital
Suita, Japan
Osaka Medical College
Takatsuki, Japan
National Defense Medical College
Tokorozawa, Japan
National Cancer Center Hospital
Tokyo, Japan
Toho University Ohashi Medical Center
Tokyo, Japan
Toho University Omori Medical Center
Tokyo, Japan
Tokyo Medical and Dental University Hospital
Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, Japan
Tochigi Cancer Center
Utsunomiya, Japan
Yamagata Prefectural Central Hospital
Yamagata, Japan
Kanagawa Cancer Center
Yokohama, Japan
Saiseikai Yokohama-shi Nanbu Hospital
Yokohama, Japan
Yokohama City University Medical Center
Yokohama, Japan
Oita University Faculty of Medicine
Yufu, Japan
Related Publications (2)
Hashimoto T, Tsukada Y, Ito M, Kanato K, Mizusawa J, Fukuda H, Tsukamoto S, Takashima A, Kanemitsu Y. Utility of circulating tumour DNA for prognosis and prediction of therapeutic effect in locally recurrent rectal cancer: study protocol for a multi-institutional, prospective observational study (JCOG1801A1, CAP-LR study). BMJ Open. 2023 Aug 16;13(8):e073217. doi: 10.1136/bmjopen-2023-073217.
PMID: 37586869DERIVEDKadota 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.
PMID: 32409830DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Masaaki Ito, MD, PhD
National Cancer Center Hospital East
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2020
First Posted
February 28, 2020
Study Start
October 1, 2019
Primary Completion
August 1, 2025
Study Completion (Estimated)
October 1, 2028
Last Updated
June 4, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share