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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01582750
• Other study ID #: CH-RO-GI-eus
• Status: Unknown status
• Phase: N/A
• First received: April 19, 2012
• Last updated: September 17, 2013
• Start date: October 2010
• Est. completion date: December 2015

Study information

• Verified date: September 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Jin, M.D.
• Phone: 861087788281
• Email: jingjin1025[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
China	Li Ning	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values		3 months