RecruitingRectal Cancer Recurrent
Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
Eligible age
20–80 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
See if you qualify for this study
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About this 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.
Sponsor: National Cancer Center Hospital East
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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.
Source: ClinicalTrials.gov · NCT04288999 · last updated 2020-06-04