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Completed

NCT Number: NCT03541304

High Dose Radiotherapy for the Treatment of Rectal Cancer

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. clinical response rate

    Time frame: evaluate 5 weeks after radiotherapy

    the rate of clinical response in the whole group

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
May 30, 2018
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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