High Dose Radiotherapy for the Treatment of Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541304
• Other study ID #: 2018-FXY-079
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 16, 2021

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 16, 2021
• Est. primary completion date: March 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response rate	the rate of clinical response in the whole group	evaluate 5 weeks after radiotherapy
Secondary	short term and long term side effects	short term and long term toxicity related to high dose radiotherapy	from the complete to 3 years after treatment
Secondary	progression free survival	defined as the time from the date of trial entry until disease progression, relapse, or death from any cause.	3 years
Secondary	overall survival	calculated from the date of trial entry until death from any cause or was censored at last follow-up	3 years