Effect of short-course radiotherapy followed by neoadjuvant Xelox (Capecitabine and Oxaliplatin) chemotherapy and total mesorectal excision in MRI defined high-risk rectal cancer: A phase II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003367

Enrollment

Registered

2018-11-22

Start date

2019-01-02

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

None listed

Interventions

Procedure/Surgery, Radiation : 1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 2,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. High-risk patients of rectal cancer on pretreatment MRI using the following risk stratification system ? Location of the lower part of the tumor is measured below less than 10 cm on the anal verge and lower part of the tumor is located below the lower limit of the peritoneal reflection. ? If there is more than one, classify as a high risk group ? Positive CRM threatening: ? 5mm ? Extramural depth ? Positive EMVI. ? cN2: ? Positive Lateral pelvic LN metastasis 2. Between 19 and 80 years of age; 3. Satisfactory performance status: ECOG?2 4. American Society of Anesthesiologists (ASA) physical status classification system class I~III 5. Adequate hematologic function: white blood cell(WBC) counts=4,000/mm3, neutrophils counts = 2,000/mm3, platelet counts = 1000,000/µL, hemoglobin = 9g/L; 6. Adequate renal function: creatinine = 1.5×upper normal limit

Exclusion criteria

Exclusion criteria: 1. The evidenc of relapse of distant metastasis 2. Receiving treatment of other anti-cancer drug or methods 3. Patients have low compliance and are not able to complete the entire trial 4. Presence of uncontrolled life-threatening diseases 5. cT4 with infiltration of anterior organ on pretreatment MRI 6. cT4 with infiltration of internal or external anal sphincter on pretreatment MRI

Design outcomes

Primary

Measure	Time frame
Pathologic complete response (pCR) rate	—

Secondary

Measure	Time frame
Incidence of acute toxocities during radiation and chemotherapy;Incidence of surgical complications;Quality of life;Cost effectiveness	—

Countries

Korea, Republic of

Contacts

Public ContactMIN SOO CHO

Yonsei University Health System, Severance Hospital

nagase96@yuhs.ac+82-2-2228-2117

Outcome results