Safety and efficacy of SOX after chemoradiation therapy

JRCT ID: jRCTs061210016

Registered date:22/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: advanced lower rectal cancer
• Date of first enrollment: 18/10/2021
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Preoperative radiochemotherapy for lower advanced rectal cancer followed by two additional courses of SOX therapy.

Outcome(s)

• Primary Outcome: Adverse events in SOX therapy

Secondary Outcome

1) Pathological complete response rate
2) Treatment completion rate
3) Time from start of SOX therapy to surgery
4) Postoperative complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Ages from 20 to 80 years old
2) Stage II or III lower rectal cancer proven to be adenocarcinoma
3) Eastern Cooperative Oncology Group performance status 0, 1
4) Patients who underwent preoperative chemoradiation therapy for stage II or III lower advanced rectal cancer
5) Patients with a S-1 dose intensity of 70% or higher during chemoradiation therapy
6) White blood cell 3000/l or more, neutrophil 1500/l or more, hemoglobin 9.0g/dl or more, platelet 100,000 or more, AST/ALT less than twice the upper limit of normal, total bilirubin 1.5mg/dl or less, eGFR 60 ml/min/1.73m2 or more
7) Patients who was obtained informed consent

Exclude criteria

1) Previous radiation therapy for pelvis
2) Involvement of adjacent organs
3) Patients who have received chemotherapy for any malignancy within the past 6 months
4) Patients with contraindications to S-1 or oxaliplatin
5) Patients with serious complications (interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, poorly controlled hypertension, heart failure, renal failure, liver cirrhosis, liver failure, etc.)
6) Pregnant or lactating women and patients with the possibility (intent) of pregnancy
7) Patients who participated in other clinical trials or clinical research and used unapproved or uninsured drugs within 3 months prior to enrollment
8) Patients judged to be inappropriate for this study

Related Information

• Primary Sponsor: Fujiwara Yoshiyuki