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

NCT ID: NCT01582750

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

endoscopic ultrasound pre-operative concurrent chemoradiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Local advanced rectal cancer EUS

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jing Jin, M.D.

Director of Abdomen Division, Radiation Oncology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jing Jin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese Acedemy of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Li Ning

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jing Jin, M.D.

Role: CONTACT

Phone: 861087788281

Email: [email protected]

Ning Li, M.D.

Role: CONTACT

Phone: 8610-87788280

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ning Li, M.D

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Li N, Dou L, Zhang Y, Jin J, Wang G, Xiao Q, Li Y, Wang X, Ren H, Fang H, Wang W, Wang S, Liu Y, Song Y. Use of sequential endorectal US to predict the tumor response of preoperative chemoradiotherapy in rectal cancer. Gastrointest Endosc. 2017 Mar;85(3):669-674. doi: 10.1016/j.gie.2016.06.042. Epub 2016 Jun 25.

Reference Type DERIVED
PMID: 27354104 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CH-RO-GI-eus

Identifier Type: -

Identifier Source: org_study_id