Skip to main content
Clinical Trials/NCT03541304
NCT03541304
Completed
Not Applicable

Efficacy and Toxicity of High Dose Radiotherapy Wich Concurrent Chemotherapy for the Treatment of Rectal Cancer

Sun Yat-sen University1 site in 1 country48 target enrollmentJanuary 1, 2017
ConditionsRectal Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Sun Yat-sen University
Enrollment
48
Locations
1
Primary Endpoint
clinical response rate
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 16, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Yuan-hong Gao

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • patients with terminal cancer who received palliative treatment;
  • patients received any treatment before admission to Sun Yat-sen University Cancer Center;
  • patients with second primary cancer.

Outcomes

Primary Outcomes

clinical response rate

Time Frame: evaluate 5 weeks after radiotherapy

the rate of clinical response in the whole group

Secondary Outcomes

  • progression free survival(3 years)
  • short term and long term side effects(from the complete to 3 years after treatment)
  • overall survival(3 years)

Study Sites (1)

Loading locations...

Similar Trials