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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: 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)

Ito Masaaki

National Cancer Center Hospital East

6-5-1, Kashiwanoha, Kashiwa, Chiba

maito@east.ncc.go.jp

Tsukada Yuichiro

National Cancer Center Hospital East

6-5-1, Kashiwanoha, Kashiwa, Chiba

+81-4-7133-1111

yutsukad@east.ncc.go.jp

Recruiting

Aug. 15, 2019

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1) Pathologically proven adenocarcinoma or adenosquamous carcinoma using the resected specimen of the initial rectal cancer or the endoscopic biopsy from the initial rectal cancer.
(2) The main tumor location of the initial rectal cancer is RS, Ra,Rb,or P.
(3) The following treatment was performed for the initial rectal cancer, and judged as R0/1 or ER0/1 in pathological diagnosis.
(i) Rectal resection (with or without lymph node dissection).
(ii) Local resection.
(iii) Endoscopic resection.
(4) The patients who had distant metastasis when or after treated for the initial rectal cancer, and radical surgical resection or radical radiotherapy was performed more than 168 days before registration is eligible.
(5) Diagnosed as reccurent rectal cancer by the following modality after treatment for the initial rectal cancer.
(i) The reccurnet lesion is pathologically diagnosed.
(ii) Diagnosed as local reccurence by more than two modality from contrast-enhanced CT, MRI, or PET.
(iii) Chronological progression of lesion is obseved by more than one modality from contrast-enhanced CT, MRI, or PET.
(6) The main tumor location is diagnosed within pelvis by contrast-enhanced CT and MRI if reccurent lesion is multiple, or reccurent lesions spread outside of pelvis continuously.
(7) Not the locally recurrent rectal cancer with any following condition.
(i) Judged as resectable endoscopically.
(ii) Diagnosed as depth of invasion within MP by contrast-enhanced CT, MRI, or PET in case of recurrence inside of intestine
(iii) Solitary ovary metastasis.
(iv) Reccurence of common iliac lymph node alone.
(8) Locally recurrent rectal cancer is judged as resectable, all of the following conditions must be fulfilled:
(i) No distant metastasis on contrast-enhanced CT (cM0).
(ii) Judged as estimated CRM>0 mm.
(iii) No need of leg amputation.
(iv) Able to preserve the first sacral nerve.
(9) No prior surgery for recurrent rectal cancer.
(10) No prior pelvic irradiation for any malignancies.
(11) The patient who had received systemic chemotherapy for any malignancies and was more than 14 days after the final administration is eligible.
(12) Age at registration is of 20 to80 years old.
(13) ECOG Performance status is 0 or 1.
(14) Measureable lesion is not mandatory.
(15) Sufficient oral intake.
(16) Sufficient organ function.
(i) Neutrophil count >= 1,500 /mm3
(ii) Hemoglobin >= 9.0 mg/dl
(iii) Platelet count >= 100,000 /mm3
(iv) Total Bilirubin =< 2.0 mg/dL
(v) AST =< 100 U/L
(vi) ALT =< 100 U/L
(vii) Cr =< 1.5 mg/dL
(17) Open surgery, laparoscopic surgery, or robotassisted surgery will be performed.
(18) Witten informed consent is obtained.

(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 which needs systemic treatment.
(3) Body temperature is higher than 38 degrees centigrade at registration.
(4) Female during pregnancy, within 28 days of postparturition, or during lactation. Men with partners anticipating conception in the near future.
(5) Severe psychological disease.
(6) Continuous systemic corticosteroid or immunosuppressant treatment.
(7) Uncontrollable diabetes mellitus.
(8) Uncontrollable hypertension.
(9) Unstable angina pectoris, or history of myocardial infarction within 6 months.
(10) Uncontrollable valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
(11) Positive HBs antigen.
(12) Positive HIV antibody.
(13) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.

Both

resectable locally recurrent rectal cancer

A: Surgery and adjuvant chemotherapy (mFOLFOX6, CAPOX , capecitabine, or 5-FU++l-LV)

B: Preoperative chemoradiotherapy, surgery, and adjuvant chemotherapy (mFOLFOX6, CAPOX , capecitabine, or 5-FU+l-LV)
Preoperative chemoradiotherapy consist of Capecitabine (day1-5, 8-12, 15-19, 22-26, 29-33, and 36-38, 1,800-3,000 mg/day) and radiotherapy (50.4 Gy/28 Fr).

Local relapse-free survival

Overall survival, Relapse-free survival, Proportion of local relapse, Proportion of distant relapse, Proportion of patients with pathological R0 resection, response rate of preoperative CRT (Group B), Pathological complete response rate (Group B), Proportion of patients who complete protocol treatment, Incidence of adverse events (adverse reactions), Quolity of life after surgery (TOI-PFC)

+81-3-3542-2511

July. 05, 2019

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