Neo-adjuvant chemotherapy for Intersphincteric resection (ISR) in Low Rectal Cancers

JRCT ID: jRCTs031180278

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rectal Cancer
• Date of first enrollment: 25/02/2013
• Target sample size: 128
• Study type: Interventional

Intervention(s)

A group: ISR + adjuvant chemotherapy (FOLFOX x 12 or XELOX x 8)
B: Neo adjuvant chemotherapy (FOLFOX x 6 or XELOX x 4) + ISR + adjuvant chemotherapy (FOLFOX x 6 or XELOX x 4)

Outcome(s)

• Primary Outcome: Relapse-free survival (RFS)
• Secondary Outcome: Local 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Ito Masaaki
• Source(s) of Monetary Support: National Cancer Center Japan
• Secondary ID(s): UMIN000009510