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Clinical Trials/NCT01582750
NCT01582750
Unknown
N/A

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

Chinese Academy of Medical Sciences1 site in 1 country40 target enrollmentOctober 2010
ConditionsRectal Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Chinese Academy of Medical Sciences
Enrollment
40
Locations
1
Primary Endpoint
Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values
Last Updated
12 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
December 2015
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jing Jin, M.D.

Director of Abdomen Division, Radiation Oncology Department

Chinese Academy of Medical Sciences

Eligibility 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.

Outcomes

Primary Outcomes

Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values

Time Frame: 3 months

Study Sites (1)

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