JCOG1915: Less intensive post-operative surveillance in low risk colorectal cancer patients

Phase 3

Recruiting

• Conditions: colorectal cancer

• Registration Number: JPRN-jRCT1030220350
• Lead Sponsor: Kanemitsu Yukihide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

1) Pathologically proven colorectal adenocarcinoma.
2) Tumor is mainly located between cecum and lower rectum.
3) Tumor resection with D2 or D3 lymph node dissection with open or laparoscopic approach was performed, regardless of with or without lateral lymph node dissection (Robotic surgery is allowed for enrollment).
4) R0 resection was performed.
5) No distant metastasis defined as
1. Chest ; Chest CT or FDG-PET/CT
2. Abdomen ; Abdomen CT or FDG-PET/CT
6) 56 days after surgery.
7) pStage I cancer, or pStage II cancer without any following factors (JSCCR classification 9th ed.);
(a) Depth of tumor: pT4,
(b) Tumor budding: BD3,
(c) Perineural invasion: Pn1,
(d) Desmoplastic reaction (DR) category: intermediate/immature
8) Age at registration is of 20 to 75 years old.
9) ECOG Performance status is 0 or 1.
10) No prior chemotherapy or radiotherapy to the abdomen or pelvis.
11) Witten informed consent is obtained

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancies
2) Infections which needs systemic treatment.
3) Severe psychological disease.
4) Continuous systemic corticosteroid or immunosuppressant treatment.
5) Routine thoracoabdominal and pelvic CT scan at least once a year due to past medical history / comorbidities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified