Testing Radiation with Chemo Before Surgery for Recurrent Rectal Cancer
Compares chemoradiotherapy before surgery with surgery and chemo in recurrent rectal cancer.
Plain-language title generated from the registry record
Registry title: Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
Key facts
- Where
- Chiba, Gifu, Hidaka, Hirakata, Hiroshima, Izumo, Kanazawa, Kashiwa, Kawagoe, Kochi, Kumamoto, Kurashiki, Kurume, Matsuyama, Mitaka, Morioka, Nagoya, Niigata, Nishinomiya, Ōgaki, Okayama, Osaka, Ōta-ku, Saitama, Sapporo, Sendai, Shizuoka, Suita, Takatsuki, Tokorozawa, Tokyo, Utsunomiya, Yamagata, Yokohama, and Yufu, JapanSee the 45 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 80 years old?
Source: NCT04288999, who can take part
Where in Japan
- Chiba Cancer CenterChiba, JapanTaking people
- Gifu University School of MedicineGifu, JapanTaking people
- Saitama Medical University International Medical CenterHidaka, JapanNot yet recruiting
- Kansai Medical University HospitalHirakata, JapanNot yet recruiting
- Hiroshima City Asa Citizens HospitalHiroshima, JapanTaking people
- Hiroshima City HospitalHiroshima, JapanTaking people
- Shimane University Faculty of MedicineIzumo, JapanTaking people
- Ishikawa Prefectural Central HospitalKanazawa, JapanTaking people
- National Cancer Center Hospital EastKashiwa, JapanTaking people
- Saitama Medical Center, Saitama Medical UniversityKawagoe, JapanTaking people
- Kochi Health Sciences CenterKochi, JapanTaking people
- Kumamoto University HospitalKumamoto, JapanTaking people
- Kurashiki Central HospitalKurashiki, JapanTaking people
- Kurume University School of MedicineKurume, JapanTaking people
- National Hospital Organization Shikoku Cancer CenterMatsuyama, JapanTaking people
- Kyorin University Faculty of MedicineMitaka, JapanTaking people
- Iwate Medical UniversityMorioka, JapanNot yet recruiting
- Nagoya University Graduate School of MedicineNagoya, JapanNot yet recruiting
- Niigata Cancer Center HospitalNiigata, JapanTaking people
- Hyogo College of MedicineNishinomiya, JapanTaking people
- Ogaki Municipal HospitalŌgaki, JapanTaking people
- Okayama Saiseikai General HospitalOkayama, JapanTaking people
- National Hospital Organization Osaka National HospitalOsaka, JapanTaking people
- Osaka City General HospitalOsaka, JapanTaking people
- Gunma Prefectural Cancer CenterŌta-ku, JapanTaking people
- Saitama Cancer CenterSaitama, JapanTaking people
- Sapporo-Kosei General HospitalSapporo, JapanTaking people
- Miyagi Cancer CenterSendai, JapanTaking people
- Shizuoka Cancer CenterShizuoka, JapanTaking people
- Osaka University Graduate School of MedicineSuita, JapanTaking people
- Suita Municipal HospitalSuita, JapanTaking people
- Osaka Medical CollegeTakatsuki, JapanTaking people
- National Defense Medical CollegeTokorozawa, JapanTaking people
- National Cancer Center HospitalTokyo, JapanTaking people
- Toho University Ohashi Medical CenterTokyo, JapanTaking people
- Toho University Omori Medical CenterTokyo, JapanNot yet recruiting
- Tokyo Medical and Dental University HospitalTokyo, JapanTaking people
- Tokyo Medical University HospitalTokyo, JapanTaking people
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalTokyo, JapanTaking people
- Tochigi Cancer CenterUtsunomiya, JapanTaking people
- Yamagata Prefectural Central HospitalYamagata, JapanTaking people
- Kanagawa Cancer CenterYokohama, JapanTaking people
- Saiseikai Yokohama-shi Nanbu HospitalYokohama, JapanTaking people
- Yokohama City University Medical CenterYokohama, JapanTaking people
- Oita University Faculty of MedicineYufu, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Center Hospital East
- Trial code
- NCT04288999
- Record updated
- 4 June 2020
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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; Surgical resection (including local resection, with or without lymph node dissection); 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; 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); 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:; 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: Continuous systemic corticosteroid or immunosuppressant treatment; 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; Severe psychological disease; 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; 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; Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.