Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

High Dose Radiotherapy for the Treatment of Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541304
Recruitment Status : Unknown
Verified January 2019 by Yuan-hong Gao, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : May 30, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Yuan-hong Gao, Sun Yat-sen University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

While surgery remains the standard treatment for rectal cancer, some patients still firmly refuse surgery for various reasons. Here, we conducted this retrospective observation study to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating rectal cancer We retrospectively collect data of rectal cancer patients who were treated with high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April 1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician.

After treatment, patients were followed every 3 months for the first two years, at least every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded.

Analyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local recurrence and distant metastasis rate, progression free survival, and overall survival were calculated using the Kaplan Meier Method and were compared by log-rank test.


Condition or disease
Rectal Cancer

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Efficacy and Toxicity of High Dose Radiotherapy Wich Concurrent Chemotherapy for the Treatment of Rectal Cancer
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : December 3, 2021
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. clinical response rate [ Time Frame: evaluate 5 weeks after radiotherapy ]
    the rate of clinical response in the whole group


Secondary Outcome Measures :
  1. short term and long term side effects [ Time Frame: from the complete to 3 years after treatment ]
    short term and long term toxicity related to high dose radiotherapy

  2. progression free survival [ Time Frame: 3 years ]
    defined as the time from the date of trial entry until disease progression, relapse, or death from any cause.

  3. overall survival [ Time Frame: 3 years ]
    calculated from the date of trial entry until death from any cause or was censored at last follow-up


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This retrospective study included subjects identified from the database of the Sun Yat-sen University Cancer Center in the period of April 2006 to July 2017.
Criteria

Inclusion Criteria:

  1. pathologically confirmed diagnosis of rectal adenocarcinoma located within 15cm from the anal verge;
  2. pelvic radiation with a total dose ≥60Gy for the treatment of rectal cancer;
  3. refused surgery as the initial treatment;
  4. a complete set of clinical information and follow-up data.

Exclusion Criteria:

  1. patients with terminal cancer who received palliative treatment;
  2. patients received any treatment before admission to Sun Yat-sen University Cancer Center;
  3. patients with second primary cancer.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541304


Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yuan-hong Gao, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03541304    
Other Study ID Numbers: 2018-FXY-079
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuan-hong Gao, Sun Yat-sen University:
high dose radiotherapy
rectal cancer
Additional relevant MeSH terms:
Layout table for 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