Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer

April 21, 2026 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer: A Prospective, Single-arm, Phase II Study

Research Objectives and Principles: Through a prospective study, explore the effectiveness and safety of stereotactic body radiation therapy (SBRT) in the treatment of unresectable locally recurrent rectal cancer (ULRRC), providing high-level evidence for the use of SBRT in ULRRC treatment.

Primary Objective: 1-year local progression-free survival (LPFS) . Secondary Objectives: R0 resection rate and overall survival (OS), 2-year LPFS and OS, and side effects of the treatment.

Study Design: A single-arm, open-label, prospective phase II study. Study Population and Expected Enrollment: Patients with unresectable locally recurrent rectal adenocarcinoma, with an expected enrollment of 40 patients.

Scheduled Visits and Duration: December 2024 to November 2027. Trial Duration: December 2024 to November 2027. Intervention: SBRT for unresectable locally recurrent rectal cancer. Statistical Hypothesis: Enrolled patients are those with unresectable recurrent rectal cancer. Based on previous literature reports and retrospective clinical data from our center, it is hypothesized that the 1-year LPFS for patients with unresectable locally recurrent colorectal cancer who do not receive SBRT is 20%, while the 1-year LPFS for those receiving SBRT intervention is 40%. Using Simon's optimal two-stage study design, a single-arm study, with α set at 0.05 and 1-β at 0.80, and an expected loss to follow-up rate of 10%.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent;
  2. 18-75 years of age;
  3. Histologically, cytologically, or radiologically confirmed tumor recurrence, and the MDT assesses that the recurrent lesion cannot achieve R0 resection (unresectable defined as: 1) Pelvic MRI shows infiltration of S2 or above, 2) and/or lateral pelvic invasion, 3) and/or neurovascular invasion of the pelvic, 4) No indication for R0 resection after MDT discussion);
  4. No clear distant metastasis at the time of diagnosis of locally recurrent rectal adenocarcinoma or MDT assesses that oligometastatic lesions are resectable or controlable (UICC 8th edition);
  5. No previous radiotherapy for initial treatment, or more than 6 months between completion of initial radiotherapy and start of re-radiotherapy, with a previous radiotherapy dose of less than 50.4 Gy, and no grade 3-4 radiotherapy side effects in the small intestine or bladder;
  6. ECOG score for performance status is 0-1 (Appendix 1);

  7. Peripheral blood cell counts and liver and kidney function within the following acceptable ranges (tested within 15 days before treatment):

    • White blood cell count more than 3.0×10^9/L or neutrophils more than 1.5×10^9/L;

      • Hemoglobin more than 80 g/L; ③ Platelets more than 100×10^9/L; ④ ALT or AST less than 3 times the upper limit of normal; ⑤ Total bilirubin less than 1.5 times the upper limit of normal; ⑥ Creatinine less than 1.5 times the upper limit of normal;
  8. No history of other malignant tumors, non-pregnant or lactating patients, participants must use effective contraception during the study and for 6 months after the last treatment;
  9. Expected survival more than 12 months.

Exclusion Criteria:

  1. Patients with a history of severe allergies to drugs, including platinum-based drugs, 5-FU, LV, and 5-HT3 receptor antagonists;
  2. Patients who have participated in or are participating in other clinical trials within 4 weeks of enrollment;
  3. Severe electrolyte abnormalities;
  4. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or unresected tumors that are actively bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment;
  5. History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding history or bleeding tendency within 2 months;
  6. Pregnant or lactating women or women with a positive pregnancy test before the first medication; or female participants and their partners unwilling to strictly use contraception during the study;
  7. Brain metastases with a diameter greater than 3 cm or a total volume greater than 30 cc;
  8. Clinical or radiological evidence of spinal cord compression, or tumors within 3 mm of the spinal cord on MRI;
  9. History of other active malignant tumors (except for those who have received curative treatment and have been disease-free for over 3 years or in situ cancers that can be cured with adequate treatment);
  10. Severe ECG abnormalities, active coronary artery disease, or severe and uncontrolled angina, newly diagnosed angina, or myocardial infarction within 12 months before participating in the study, congestive heart failure of NYHA class II or above;
  11. Patients with active infections (fever above 38°C due to infection);
  12. Patients with poorly controlled hypercalcemia, high blood pressure, or diabetes;
  13. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
  14. Patients with mental disorders affecting clinical treatment or a history of central nervous system diseases;
  15. Patients with severe complications (intestinal obstruction, renal failure, liver failure, cerebrovascular disorders, etc.);
  16. Any unresolved toxicity from previous treatments that is grade 2 or higher according to CTCAE (excluding anemia, alopecia, skin pigmentation);
  17. Any medical condition that is unstable or may affect patient safety and study compliance;
  18. Patients deemed unsuitable for participation in this study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
SBRT for unresectable locally recurrent rectal cancer
Radiation: Stereotactic Body Radiation Therapy (SBRT)
SBRT for unresectable locally recurrent rectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1-year local progression-free survival (LPFS)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
1-year overall survival (OS)
Time Frame: 1 year
1 year
R0 resection rate
Time Frame: 2 years
2 years
2-year local progression-free survival (LPFS)
Time Frame: 2 years
2 years
2-year overall survival (OS)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBRT-ULRRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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