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Phase I/II trial of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population.

Phase I/II trial of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population. - Preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003701
Enrollment
38
Registered
2010-06-07
Start date
2010-06-01
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

rectal cancer

Interventions

Preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer.

Sponsors

Wakayama Medical University, Second Department of Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Stage II and III respectable locally advanced rectal cancer confirmed with colonoscopy, endoscopic ultrasonography, computed tomography, and magnetic resonance imaging. 2. ECOG performance status: 0-2. 3. Age: 20-80. 4. White blood cells: 2000/mm3-15000/mm3, Platelet >7.5/mm3, GPT <150IU/L, T-bil <3.0g/dL. 5. patient providing informed consent.

Exclusion criteria

Exclusion criteria: 1. Stage IV rectal cancer, rectal cancer with bowel obstruction. 2. Pregnancy. 3. Lactation. 4. Pregnancy attempy. 5. Infectious diseases. 6. Use of immunosuppressive drug and steroid. 7. Double cancer. 8. Injury and wound. 9. Paralytic ileus and interstitial pneumonia. 10. Doctor's exclusion decision.

Design outcomes

Primary

MeasureTime frame
Safety Side effect including clinical symptoms and blood examination.

Secondary

MeasureTime frame
Efficacy Pathologic complete response rate, pathological downstaging, sphincter preservation, survival, local recurrence, urinary disorder, and anorectal disorder.

Countries

Japan

Contacts

Public ContactShozo Yokoyama

Wakayama Medical University Second Department of Surgery

yokoyama@wakayama-med.ac.jp073(447)2300(5112)

Outcome results

None listed

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