Safety and efficacy of SOX after chemoradiation therapy

A phase I study of the safety and efficacy of SOX therapy after preoperative chemoradiotherapy in lower advanced rectal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061210016

Enrollment

Registered

2021-06-22

Start date

2021-06-22

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

advanced lower rectal cancer rectal cancer

Interventions

Preoperative radiochemotherapy for lower advanced rectal cancer followed by two additional courses of SOX therapy.

SOX therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Adverse events in SOX therapy	—

Secondary

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

Contacts

Public ContactManabu Yamamoto

Tottori University Hospital

m.yamamoto@tottori-u.ac.jp+81-859-38-6567

Outcome results

None listed

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