Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
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%.
Eligibility criteria
Qualifiers
Written informed consent;
18-75 years of age;
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);
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);
Disqualifiers
Patients with a history of severe allergies to drugs, including platinum-based drugs, 5-FU, LV, and 5-HT3 receptor antagonists;
Patients who have participated in or are participating in other clinical trials within 4 weeks of enrollment;
Severe electrolyte abnormalities;
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;
Trial design
Treatments tested in this trial
- Stereotactic Body Radiation Therapy (SBRT)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov