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

• Conditions: Rectal Cancer

• Registration Number: NCT01582750
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-23
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-17
• Last Update Posted: 2013-09-19
• Primary Completion: 2014-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values	3 months

Trial Locations

Locations (1)

Li Ning; 🇨🇳 Beijing, Beijing, China