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)

Completed

• Conditions: Lower rectal cancer with suspected lateral pelvic node metastasis

• Registration Number: jRCTs031180230

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-09
• Study First Submitted: 2019-03-11
• Last Update Posted: 2020-10-24

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Phase II: Proportion of patients with R0 resection, Phase III: Overall survival