Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07297004

Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-04-24

20

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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%.

CONDITIONS

Official Title

Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent
  • Age between 18 and 75 years
  • Confirmed tumor recurrence that cannot be completely removed by surgery as assessed by a multidisciplinary team
  • No clear distant metastasis or controllable/resectable oligometastatic lesions
  • No previous radiotherapy or at least 6 months since last radiotherapy with dose less than 50.4 Gy and no severe side effects
  • ECOG performance status of 0 or 1
  • Blood counts and liver/kidney function within specified safe ranges within 15 days before treatment
  • No history of other cancers, not pregnant or breastfeeding, and use of effective contraception during and 6 months after the study
  • Expected survival time greater than 12 months
Not Eligible

You will not qualify if you...

  • History of severe allergies to platinum-based drugs, 5-FU, LV, or 5-HT3 receptor antagonists
  • Participation in other clinical trials within 4 weeks
  • Severe electrolyte imbalances
  • Active gastrointestinal diseases that may cause bleeding or perforation
  • History of arterial or deep vein thrombosis within 6 months or recent bleeding history
  • Pregnant or breastfeeding women or unwillingness to use contraception
  • Brain metastases larger than 3 cm or total volume over 30 cc
  • Spinal cord compression or tumors very close to the spinal cord
  • History of other active malignancies unless disease-free over 3 years or curable in situ cancers
  • Severe heart conditions or recent heart attack
  • Active infections with fever
  • Poorly controlled hypercalcemia, hypertension, or diabetes
  • Severe lung diseases
  • Mental disorders affecting treatment or history of central nervous system diseases
  • Severe complications like intestinal obstruction, kidney or liver failure, stroke
  • Unresolved moderate or severe toxicities from previous treatments
  • Any unstable medical condition affecting safety or study compliance
  • Investigator's judgment deeming participant unsuitable for the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

Actively Recruiting

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Research Team

J

Jian Zheng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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