Unique ID issued by UMIN | UMIN000023361 |
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Receipt number | R000026612 |
Scientific Title | A Phase II Study of Short-course Radiotherapy Preoperatively followed by Capecitabine and Oxaliplatin (XELOX) for cT3 Node-positive Lower Rectal Cancer |
Date of disclosure of the study information | 2016/08/01 |
Last modified on | 2020/07/31 19:36:26 |
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
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
Japan |
Low rectal cancer
Gastroenterology | Gastrointestinal surgery | Radiology |
Malignancy
NO
To evaluate the safety and efficacy of neoadjuvant short-course radiotherapy followed by XELOX for cT3N1 low rectal cancer at high risk of local and distant recurrence.
Safety,Efficacy
R0 resection rate
Safety (incidence of adverse events), Pathological complete response (pCR), Down-staging rate, Disease-free survival (DFS), local recurrence rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Preoperative short-course radiotherapy (5x5 Gy)
XELOX+BEV (4 courses) as neoadjuvant setting.
Capecitabine: 2000mg/m2 d1-14
Oxaliplatin: 130mg/m2 d1
Q3w
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
36
1st name | Takashi |
Middle name | |
Last name | Akiyoshi |
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Gastroenterological Surgery
135-8550
3-8-31, Ariake, Koto-ku, Tokyo
+81-3-3520-0111
takashi.akiyoshi@jfcr.or.jp
1st name | Takashi |
Middle name | |
Last name | Akiyoshi |
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Gastroenterological Surgery
135-8550
3-8-31, Ariake, Koto-ku, Tokyo
+81-3-3520-0111
takashi.akiyoshi@jfcr.or.jp
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Other
Cancer Institute Hospital of Japanese Foundation for Cancer Research
3-8-31, Ariake, Koto-ku, Tokyo
+81-3-3520-0111
s.takahashi-chemotherapy@jfcr.or.jp
NO
2016 | Year | 08 | Month | 01 | Day |
Unpublished
28
Completed
2016 | Year | 04 | Month | 13 | Day |
2016 | Year | 07 | Month | 07 | Day |
2016 | Year | 07 | Month | 07 | Day |
2023 | Year | 07 | Month | 07 | Day |
2016 | Year | 07 | Month | 27 | Day |
2020 | Year | 07 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026612
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