Randomized study of Conventional technique vs. No-touch isolation technique (JCOG1006, NTIT study)

Randomized study of Conventional technique vs. No-touch isolation technique (JCOG1006, NTIT study) - Randomized controlled study of Conventional technique vs. No-touch isolation technique in patients with colon cancer (JCOG1006, NTIT study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004957

Enrollment

850

Registered

2011-01-26

Start date

2011-01-26

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

colon cancer

Interventions

A: Conventional technique B: No-touch isolation technique

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Endoscopic biopsy revealed that the tumor was pathologically proven adenocarcinoma (including muc and sig) or adenosquamous carcinoma. 2. Preoperative endoscopy and radiographical imaging (barium enema or CT) revealed that the tumor was located at Cecum, Ascending, Transverse, Descending, Sigmoid, or Rectosigmoid, and lower border of the tumor was not located at revtum. 3. Preoperative radiographical imaging fulfills all of the following conditions: i) tumor depth of SS, SE, SI, A, or AI, ii) nodal metastasis of N0, N1, or N2, iii) neither H0, P0, nor M0. 4. No multiple colon cancer. 5. Aged 20 to 80 years old. 6. ECOG performance status of 0 or 1. 7. No prior chemotherapy or radiotherapy for any malignancies. 8. Sufficient organ functions. 9. Body mass index of less than 30. 10. No history of intestinal resection, serious obstruction or perforation. 11. No history of familial adenomatous polyposis, ulcerative colitis, or Crohn's disease. 12. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Simultaneous or metachronous (within 5 years) double cancers. 2. Infectius disease to be treated. 3. Body temperature of 38C or higher. 4. Women during pregnancy or breast-feeding. 5. Psychiatric diseases. 6. Systemic and continuous steroids medication. 7. History of myocardial infarction within 6 months or unstable angina pectoris within 6 months. 8. Severe pulmonary emphysema or pulmonary fibrosis.

Design outcomes

Primary

Measure	Time frame
Disease-free survival	—

Secondary

Measure	Time frame
Overall survival, Relapse-free survival, liver metastasis-free survival, mode of recurrence, surgical morbidity, adverse events by post-operative chemotherapy, serious adverse events (Grade 4 non-hematological toxicity, early death, treatment-related death), short-term clinical outcomes	—

Countries

Japan

Contacts

Public ContactYasukimi Takii

JCOG1006 Coordinating Office Surgical Division, Niigata Cancer Center Hospital

JCOG_sir@ml.jcog.jp025-266-5111

Outcome results

None listed

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