Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy
1 other identifier
observational
40
1 country
1
Brief Summary
The purpose of this study is to determine the role of endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values in predicting the tumor regression after concurrent chemoradiotherapy for rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 19, 2013
September 1, 2013
3.9 years
April 19, 2012
September 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values
3 months
Study Arms (1)
Local advanced rectal cancer EUS
Eligibility Criteria
Local advanced rectal cancer
You may qualify if:
- pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0).
- tumor distance from anus less than 12 cm.
- KPS score not less than 70
- can be tolerated chemotherapy and radiotherapy.
- pelvic who had no history of radiation therapy.
- Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
- a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent.
You may not qualify if:
- other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
- pregnant or lactating patients.
- fertility but did not use contraceptive measures.
- existing active infection.
- merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
- concurrent treatment with other anticancer drugs.
- can not complete treatment or follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Li Ning
Beijing, Beijing Municipality, 100021, China
Related Publications (1)
Li N, Dou L, Zhang Y, Jin J, Wang G, Xiao Q, Li Y, Wang X, Ren H, Fang H, Wang W, Wang S, Liu Y, Song Y. Use of sequential endorectal US to predict the tumor response of preoperative chemoradiotherapy in rectal cancer. Gastrointest Endosc. 2017 Mar;85(3):669-674. doi: 10.1016/j.gie.2016.06.042. Epub 2016 Jun 25.
PMID: 27354104DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Jin, M.D.
Chinese Acedemy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Abdomen Division, Radiation Oncology Department
Study Record Dates
First Submitted
April 19, 2012
First Posted
April 23, 2012
Study Start
October 1, 2010
Primary Completion
September 1, 2014
Study Completion
December 1, 2015
Last Updated
September 19, 2013
Record last verified: 2013-09