eo-adjuvant chemotherapy for Intersphincteric resection (ISR) in Low Rectal Cancers
- Conditions
- Rectal Cancerrectal cancer
- Registration Number
- JPRN-jRCTs031180278
- Lead Sponsor
- Ito Masaaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 128
1) Rectal cancer located within 5cm from the anal verge of 3cm from the dentate line
2) Histologically proven adenocarcinoma
3) Clinical T3 N-any M0
4) Without invasion to the external anal sphincter
5) Radical surgery is expected
6) Age: 20 yr.<= <=75 yr.
7) Having enough organ function as follows
1. WBC > 3,000/mm3
2. Plt > 100,000/mm3
3. Hb > 8.0g/dl
4. GOT < 100IU/L
5. GPT < 100IU/L
6. T-Bil. < 2.0mg/dl
7. Cr < 1.5mg/dl
8. PT > 50%
8) Performance Status (ECOG):0 or 1
9) No history of chemotherapy or radiotherapy
10) The consent in writing has obtained
1) Hoping APR
2) Undergoing ISR is difficult
3) Having severe anal dysfunction before surgery
4) Double cancers
5) Having severe complications as follows:
1.Poor controlled Diabetes Mellitus
2.Poor controlled hypertension
3.Interstitial pneumonia, Pulmonary fibrosis, Severe emphysema
6) Chronic active type B or type C hepatitis
7) Blood transfusion within 2 weeks
8) Pregnant or Lactating
9) Inadequate due to mental illness or mental symptoms
10) The consent has not obtained
11) Judged by doctors as inadequate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival (RFS)
- Secondary Outcome Measures
Name Time Method ocal recurrent rate (3yr.), Overall survival (3yr.), RFS of patients with/without lateral lymphnode dissection (3yr.), Completeness of protocol treatment, Radical resection rate, Safety of surgery and chemotherapy, Anal preserving rate, Anal function, Quality of life, Response rate of neoadjuvant chemotherapy, Peripheral neuropathy