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

This study is currently recruiting participants.
Verified September 2013 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01582750
First received: April 19, 2012
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

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: 40
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Local advanced rectal cancer EUS

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 19, 2012
Last Updated: September 17, 2013
Health Authority: China: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014