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JCOG1310: A phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis (PRECIOUS trial)

JCOG1310: A phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis (PRECIOUS trial)

48

Please find the "JCOG1310 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.

Please find the "JCOG1310 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.

Please find the "JCOG1310 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.

Please find the "JCOG1310 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.

This study had a planned accrual period of 7 years but was terminated due to poor accrual of patients 4 years after the start of enrollment. The number of final enrolled patients was 48, which is 14.5% of the planned 330. Therefore, the statistical power of this study is very low and some definite conclusions cannot be drawn from this study.

Oct. 24, 2020

Yes

Individual patient-level-data will be provided only when Colorectal Cancer Study Group of JCOG accept the offer after publishing primary analysis result. JCOG chair will make the final decision whether data sharing should be accepted or not. Data sharing information will be released at the JCOG website. JCOG Data Center will receive program, log, and output for the analysis.

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180230

Ohue Masayuki

Osaka International Cancer Institute

3-1-69 Ohtemae, Chuo-ku, Osaka

ohue-ma@mc.pref.osaka.jp

Ohue Masayuki

Osaka International Cancer Institute

3-1-69 Ohtemae, Chuo-ku, Osaka

+81-6-6945-1181

ohue-ma@mc.pref.osaka.jp

Complete

May. 18, 2015

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Pathologically proven adenocarcinoma or adenosquamous carcinoma
2. Primary tumor located at Upper rectum, Lower rectum, and Anal canal
3. The lower border of the tumor located between the peritoneal reflection and the anal verge
4. cT2, cT3, and cT4 tumor on contrast-enhanced CT or MRI, except T4b tumor invading the trigone of bladder, urethra, or sacrum
5. Lateral lymph nodes with 10mm or more in short axis diameter on contrast-enhanced CT or MRI data of 5mm-thickness slices (cN3)
6. No distant metastasis on contrast-enhanced CT or MRI (cM0)
7. Aged 20 to 74 years old
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. No prior chemotherapy or treatment such as rectal resection, pelvic lymph node dissection, or pelvic irradiation for any malignancies
10. No other colorectal carcinoma, except cTis or cT1a
11. Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment
1) Neutrophil count >= 1,500 /mm3
2) Platelet count >= 100,000 /mm3
3) T.Bil =< 2.0 mg/dL
4) AST =< 100 IU/L
5) ALT =< 100 IU/L
6) Cr =< 1.5 mg/dL
12. Open surgery or laparoscopic surgery will be performed
13. Written informed consent

1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
2) Infectious disease to be treated
3) Positive for HBs antigen
4) Body temperature >= 38 degrees Celsius
5) Women during pregnancy, possible pregnancy or breast-feeding
6) Severe mental disease
7) Currently treated with systemic steroids or immunosuppressive agents
8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT
9) Uncontrollable diabetes mellitus or routine administration of insulin
10) Unstable angina pectoris or previous myocardial infarction within the past 6 months

Both

Lower rectal cancer with suspected lateral pelvic node metastasis

A: T(S)ME+LND and postoperative chemotherapy (mFOLFOX6 12 cycles)
B: preoperative chemotherapy (mFOLFOX6 6 cycles), T(S)ME+LND, and postoperative chemotherapy (mFOLFOX6 6 cycles)

Phase II: Proportion of patients with R0 resection, Phase III: Overall survival

Phase II part: Proportion of operative complication, Proportion of patients who complete 12 cycles of chemotherapy
Phase III part: Progression-free survival, Local progression-free survival, Proportion of patients with R0 resection, Overall response rate of preoperative chemotherapy (Group B), Pathological complete response rate (Group B), Proportion of patients who complete 12 cycles of chemotherapy, Incidence of adverse events, Incidence of serious adverse events, Proportion of operative complication, Proportion of preservation of adjacent organs, Proportion of anus-preservation, Proportion of anus-preservation without stoma

+81-3-3542-2511

Nov. 22, 2018

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