Actively Recruiting
Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
Led by National Cancer Center Hospital East · Updated on 2020-06-04
110
Participants Needed
45
Research Sites
469 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center Hospital East
Lead Sponsor
J
Japan Clinical Oncology Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma or adenosquamous carcinoma of the initial rectal cancer.
- Tumor located in upper, middle, or lower rectum or anal canal.
- Previous treatment for initial rectal cancer was surgical resection or endoscopic resection with R0/1 or ER0/1 status.
- Patients with distant metastasis treated with radical surgery or radiotherapy more than 168 days before registration are eligible.
- Locally recurrent rectal cancer diagnosed by pathology or imaging with progression.
- Main tumor located within the pelvis or continuous spread outside pelvis.
- No conditions such as resectable endoscopic lesions, shallow invasion, solitary ovarian metastasis, or isolated common iliac lymph node recurrence.
- Locally recurrent rectal cancer must be resectable with no distant metastasis, clear margins estimated, no leg amputation needed, and first sacral nerve preservation possible.
- No prior surgery for recurrent rectal cancer.
- No prior pelvic irradiation.
- Systemic chemotherapy for any malignancy completed at least 14 days before.
- Age 20 to 80 years.
- ECOG performance status 0 or 1.
- Measurable lesion not mandatory.
- Adequate oral intake.
- Adequate organ function (specific blood counts and liver/kidney function levels).
- Planned open or laparoscopic surgery.
- Signed informed consent obtained.
You will not qualify if you...
- Synchronous or metachronous malignancies within 5 years except those with very high survival rates.
- Infections requiring systemic treatment.
- Fever above 38 degrees Celsius at registration.
- Pregnancy, recent childbirth, lactation, or male partners planning conception soon.
- Severe psychological disorders.
- Continuous systemic corticosteroid or immunosuppressant use.
- Uncontrolled diabetes or hypertension.
- Unstable angina or recent myocardial infarction.
- Uncontrolled valvular heart disease or cardiomyopathies.
- Positive Hepatitis B or C virus tests.
- Positive HIV test.
- Severe lung diseases shown on chest CT such as interstitial pneumonia, fibrosis, or emphysema.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
Chiba Cancer Center
Chiba, Japan
Actively Recruiting
2
Gifu University School of Medicine
Gifu, Japan
Actively Recruiting
3
Saitama Medical University International Medical Center
Hidaka, Japan
Not Yet Recruiting
4
Kansai Medical University Hospital
Hirakata, Japan
Not Yet Recruiting
5
Hiroshima City Asa Citizens Hospital
Hiroshima, Japan
Actively Recruiting
6
Hiroshima City Hospital
Hiroshima, Japan
Actively Recruiting
7
Shimane University Faculty of Medicine
Izumo, Japan
Actively Recruiting
8
Ishikawa Prefectural Central Hospital
Kanazawa, Japan
Actively Recruiting
9
National Cancer Center Hospital East
Kashiwa, Japan
Actively Recruiting
10
Saitama Medical Center, Saitama Medical University
Kawagoe, Japan
Actively Recruiting
11
Kochi Health Sciences Center
Kochi, Japan
Actively Recruiting
12
Kumamoto University Hospital
Kumamoto, Japan
Actively Recruiting
13
Kurashiki Central Hospital
Kurashiki, Japan
Actively Recruiting
14
Kurume University School of Medicine
Kurume, Japan
Actively Recruiting
15
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Actively Recruiting
16
Kyorin University Faculty of Medicine
Mitaka, Japan
Actively Recruiting
17
Iwate Medical University
Morioka, Japan
Not Yet Recruiting
18
Nagoya University Graduate School of Medicine
Nagoya, Japan
Not Yet Recruiting
19
Niigata Cancer Center Hospital
Niigata, Japan
Actively Recruiting
20
Hyogo College of Medicine
Nishinomiya, Japan
Actively Recruiting
21
Okayama Saiseikai General Hospital
Okayama, Japan
Actively Recruiting
22
National Hospital Organization Osaka National Hospital
Osaka, Japan
Actively Recruiting
23
Osaka City General Hospital
Osaka, Japan
Actively Recruiting
24
Ogaki Municipal Hospital
Ōgaki, Japan
Actively Recruiting
25
Gunma Prefectural Cancer Center
Ōta-ku, Japan
Actively Recruiting
26
Saitama Cancer Center
Saitama, Japan
Actively Recruiting
27
Sapporo-Kosei General Hospital
Sapporo, Japan
Actively Recruiting
28
Miyagi Cancer Center
Sendai, Japan
Actively Recruiting
29
Shizuoka Cancer Center
Shizuoka, Japan
Actively Recruiting
30
Osaka University Graduate School of Medicine
Suita, Japan
Actively Recruiting
31
Suita Municipal Hospital
Suita, Japan
Actively Recruiting
32
Osaka Medical College
Takatsuki, Japan
Actively Recruiting
33
National Defense Medical College
Tokorozawa, Japan
Actively Recruiting
34
National Cancer Center Hospital
Tokyo, Japan
Actively Recruiting
35
Toho University Ohashi Medical Center
Tokyo, Japan
Actively Recruiting
36
Toho University Omori Medical Center
Tokyo, Japan
Not Yet Recruiting
37
Tokyo Medical and Dental University Hospital
Tokyo, Japan
Actively Recruiting
38
Tokyo Medical University Hospital
Tokyo, Japan
Actively Recruiting
39
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, Japan
Actively Recruiting
40
Tochigi Cancer Center
Utsunomiya, Japan
Actively Recruiting
41
Yamagata Prefectural Central Hospital
Yamagata, Japan
Actively Recruiting
42
Kanagawa Cancer Center
Yokohama, Japan
Actively Recruiting
43
Saiseikai Yokohama-shi Nanbu Hospital
Yokohama, Japan
Actively Recruiting
44
Yokohama City University Medical Center
Yokohama, Japan
Actively Recruiting
45
Oita University Faculty of Medicine
Yufu, Japan
Actively Recruiting
Research Team
Y
Yuichiro Tsukada, MD,PhD
CONTACT
M
Masaaki Ito, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here