A Phase II Study of Short-course Radiotherapy Preoperatively followed by Capecitabine and Oxaliplatin (XELOX) for cT3 Node-positive Lower Rectal Cancer

A Phase II Study of Short-course Radiotherapy Preoperatively followed by Capecitabine and Oxaliplatin (XELOX) for cT3 Node-positive Lower Rectal Cancer - ADVANCE-RC study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023361

Enrollment

Registered

2016-08-01

Start date

2016-07-07

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

Low rectal cancer

Interventions

Preoperative short-course radiotherapy (5x5 Gy) XELOX+BEV (4 courses) as neoadjuvant setting. Capecitabine: 2000mg/m2 d1-14 Oxaliplatin: 130mg/m2 d1 Q3w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological confirmation of adenocarcinoma. 2. The inferoior border of the tumor below the peritoneal reflection. 3. No distant metastases. 4. No lateral lymph node metastases. 5. Pelvic MRI shows i) cT3, ii) cN1 or extramural vascular invasion (EMVI+), and iii) circumferential resection margin (CRM) >1mm 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 7. No previous preoperative radiotherapy or chemotherapy for rectal cancer. 8. Age: 20- years old. 9. Written informed consent. 10. Vital organ functions (listed below) are preserved within 2 weeks prior to entry. i. Neutrophils>or=1500/mm3 ii. Platelets>or=100,000/mm3 iii. Hemoglobin>or=9.0g/dl iv. AST, ALT and ALP =or<upper limit of normal (ULN)*2.5 v. Total bilirubin =or<upper limit of normal (ULN)*1.5 vi. Serum creatinine =or<upper limit of normal (ULN)*1.5 11. If there is bowel obstruction or strong stricture, stoma construction before preoperative therapy.

Exclusion criteria

Exclusion criteria: 1. cT4 or cN2. 2. CRM less than 1mm. 3. Administration contraindication of oxaliplatin or capecitabine. 4. History of the serious hypersensitivity for any agents. 5. History of pelvic irradiation. 6. Uncontrolled active infection. 7. Clinically significant complication (heart failure, interstitial lung disease or pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure, etc.) 8. Evidence of peripheral sensory neuropathy. 9. Uncontrolled diarrhea. 10. Uncontrolled pleural effusion or ascites. 11. Multiple primary cancer within 5 years. 12. Possible pregnant, pregnant or breast-feeding female. 13. Other conditions not suitable for this study.

Design outcomes

Primary

Measure	Time frame
R0 resection rate	—

Secondary

Measure	Time frame
Safety (incidence of adverse events), Pathological complete response (pCR), Down-staging rate, Disease-free survival (DFS), local recurrence rate	—

Countries

Japan

Contacts

Public ContactTakashi Akiyoshi

Cancer Institute Hospital of Japanese Foundation for Cancer Research Gastroenterological Surgery

takashi.akiyoshi@jfcr.or.jp+81-3-3520-0111

Outcome results

None listed

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