High Dose Radiotherapy for the Treatment of Rectal Cancer

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT03541304
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-30
• Primary Completion: 2019-03-16
• Study Completion: 2021-12-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical response rate	evaluate 5 weeks after radiotherapy	the rate of clinical response in the whole group

Secondary Outcome Measures

Name	Time	Method
progression free survival	3 years	defined as the time from the date of trial entry until disease progression, relapse, or death from any cause.
short term and long term side effects	from the complete to 3 years after treatment	short term and long term toxicity related to high dose radiotherapy
overall survival	3 years	calculated from the date of trial entry until death from any cause or was censored at last follow-up

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China