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

  • STATUS
    Recruiting
  • End date
    Oct 11, 2028
  • participants needed
    110
  • sponsor
    National Cancer Center Hospital East
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Updated on 11 June 2020
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ct scan
platelet count
measurable disease
carcinoma
metastasis
neutrophil count
adenocarcinoma

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.

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.

Details
Treatment Chemotherapy, Procedure, Preoperative radiotherapy
Clinical Study IdentifierNCT04288999
SponsorNational Cancer Center Hospital East
Last Modified on11 June 2020

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Eligibility

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Inclusion Criteria

Is your age between 20 yrs and 80 yrs?
Gender: Male or Female
Do you have Rectal Cancer Recurrent?
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)
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
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