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

STATUS

Recruiting
End date

Oct 29, 2028
participants needed

110
sponsor

National Cancer Center Hospital East

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Updated on 19 February 2024

See if I qualify

cancer

platelet count

ct scan

measurable disease

metastasis

neutrophil count

adenocarcinoma

chemoradiotherapy

carcinoma

systemic chemotherapy

laparoscopic surgery

open surgery

endoscopic resection

adjuvant chemotherapy

adenosquamous carcinoma

rectal cancer

recurrent rectal cancer

emission computed tomography

carcinomas

adjuvant

ovarian metastasis

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

Condition	Rectal Cancer Recurrent
Age	20years - 80years
Treatment	Chemotherapy, preoperative radiotherapy, Procedure
Clinical Study Identifier	NCT04288999
Sponsor	National Cancer Center Hospital East
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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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Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer