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Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)

Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN) - Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000105
Enrollment
818
Registered
2005-09-01
Start date
2004-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Surgery:open colectomy Surgery:laparoscopic colectomy

Sponsors

Japan Clinical Oncology Group(JCOG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: For inclusion in the study, patients must fulfill the following requirements preoperatively: (1) histologically proven colorectal carcinoma (2) tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon (3) T3 or deeper lesion without involvement of other organs (4)without multiple lesion other than carcinoma in situ (5) cancer classified as N0-2 and M0, according to the TNM classification system (6) tumor size 75 years (9) sufficient organ function (10) no history of gastrointestinal surgery (11) no history of chemotherapy or radiotherapy (12) provided written informed consent

Exclusion criteria

Exclusion criteria: Exclusion criteria are as follows: (1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (2) severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease (3) pregnant or lactating women (4) severe mental disease (5) continuous systemic steroid therapy

Design outcomes

Primary

MeasureTime frame
overall survival

Secondary

MeasureTime frame
relapse-free survival, short-term clinical outcomes, adverse events, the proportion of conversion from LAP to OPEN, the proportion of completion of LAP

Countries

Japan

Contacts

Public ContactMasafumi Inomata, MD

JCOG0404 Coordinating Office Oita University Faculty of Medicine

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026