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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023361
Receipt No. 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

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Basic information
Public title A Phase II Study of Short-course Radiotherapy Preoperatively followed by Capecitabine and Oxaliplatin (XELOX) for cT3 Node-positive Lower Rectal Cancer
Acronym ADVANCE-RC study
Scientific Title A Phase II Study of Short-course Radiotherapy Preoperatively followed by Capecitabine and Oxaliplatin (XELOX) for cT3 Node-positive Lower Rectal Cancer
Scientific Title:Acronym ADVANCE-RC study
Region
Japan

Condition
Condition Low rectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes R0 resection rate
Key secondary outcomes Safety (incidence of adverse events), Pathological complete response (pCR), Down-staging rate, Disease-free survival (DFS), local recurrence rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Preoperative short-course radiotherapy (5x5 Gy)
XELOX+BEV (4 courses) as neoadjuvant setting.
Capecitabine: 2000mg/m2 d1-14
Oxaliplatin: 130mg/m2 d1
Q3w
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Akiyoshi
Organization Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name Gastroenterological Surgery
Zip code 135-8550
Address 3-8-31, Ariake, Koto-ku, Tokyo
TEL +81-3-3520-0111
Email takashi.akiyoshi@jfcr.or.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Akiyoshi
Organization Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name Gastroenterological Surgery
Zip code 135-8550
Address 3-8-31, Ariake, Koto-ku, Tokyo
TEL +81-3-3520-0111
Homepage URL
Email takashi.akiyoshi@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization Cancer Institute Hospital of Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address 3-8-31, Ariake, Koto-ku, Tokyo
Tel +81-3-3520-0111
Email s.takahashi-chemotherapy@jfcr.or.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 28
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 13 Day
Date of IRB
2016 Year 07 Month 07 Day
Anticipated trial start date
2016 Year 07 Month 07 Day
Last follow-up date
2023 Year 07 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 27 Day
Last modified on
2020 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026612

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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