Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy
Verified September 2013 by Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
First received: April 19, 2012
Last updated: September 17, 2013
Last verified: September 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy
Primary Outcome Measures:
- Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
Local advanced rectal cancer EUS
We use endoscopic ultrasound to measure the primary tumor maximum diameter changes to predict the tumor regression after concurrent chemoradiotherapy for rectal cancer
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Local advanced rectal cancer
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582750
|Beijing, Beijing, China, 100021 |
|Contact: Ning Li, M.D 86-13810381399 firstname.lastname@example.org |
Chinese Academy of Medical Sciences
||Jing Jin, M.D.
||Chinese Acedemy of Medical Sciences
No publications provided
||Jing Jin, M.D., Director of Abdomen Division, Radiation Oncology Department, Chinese Academy of Medical Sciences
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 19, 2012
||September 17, 2013
||China: Ministry of Health
Keywords provided by Chinese Academy of Medical Sciences:
ClinicalTrials.gov processed this record on March 03, 2015
pre-operative concurrent chemoradiotherapy