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Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy

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ClinicalTrials.gov Identifier: NCT01582750
Recruitment Status : Unknown
Verified September 2013 by Jing Jin, M.D., Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : April 23, 2012
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences

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.

Condition or disease
Rectal Cancer

Detailed Description:
We use endoscopic ultrasound to measure the primary tumor maximum diameter changes to predict the tumor regression after concurrent chemoradiotherapy for rectal cancer

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy
Study Start Date : October 2010
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Ultrasound
U.S. FDA Resources

Group/Cohort
Local advanced rectal cancer EUS



Primary Outcome Measures :
  1. Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Local advanced rectal cancer
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582750


Contacts
Contact: Jing Jin, M.D. 861087788281 jingjin1025@163.com
Contact: Ning Li, M.D. 8610-87788280 vista2400@gmail.com

Locations
China, Beijing
Li Ning Recruiting
Beijing, Beijing, China, 100021
Contact: Ning Li, M.D    86-13810381399    lee_ak@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Jing Jin, M.D. Chinese Acedemy of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jing Jin, M.D., Director of Abdomen Division, Radiation Oncology Department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01582750     History of Changes
Other Study ID Numbers: CH-RO-GI-eus
First Posted: April 23, 2012    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by Jing Jin, M.D., Chinese Academy of Medical Sciences:
endoscopic ultrasound
pre-operative concurrent chemoradiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases