Rectal Neoplasms Clinical Trial
— SUNRISEOfficial title:
MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy (SCPRT) Followed by Consolidation Chemotherapy Versus Long Course Chemoradiation for Unresectable Rectal Cancer
Improvements in downstaging are required when using preoperative chemoradiation for unresectable rectal cancer. There is therefore a need to explore more effective schedules. The study arm will receive MRI simulation-guided boost in short-course preoperative radiotherapy followed by consolidation chemotherapy , which may enhance the shrinkage of tumor comparing with the concurrent chemoradiation.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Biopsy proven rectal adenocarcinoma; - Distance between tumour and anal verge= 10cm; - Locally advanced tumour;(AJCC Cancer Staging:T3, T4 or N+) - Mesorectal fascia(MRF)+ or T4b evaluated by pelvic MRI; - Eastern Cooperative Oncology Group(ECOG) performance score = 1; - Written informed consent; - Mentally and physically fit for chemotherapy; - Adequate blood counts: White blood cell count =3.5 x 109/L Haemoglobin levels =100g/L Platelet count =100 x 109/L Creatinine levels =1.0× upper normal limit(UNL) Urea nitrogen levels =1.0× upper normal limit(UNL) Alanine aminotransferase(ALT) =1.5× upper normal limit(UNL) Aspartate aminotransferase(AST) =1.5× upper normal limit(UNL) Alkaline phosphatase(ALP) =1.5× upper normal limit(UNL) Total bilirubin(TBIL) =1.5× upper normal limit(UNL) - No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis. Exclusion Criteria: - Distant metastases; - Recurrent rectal cancer; - Active Crohn's disease or ulcerative colitis; - Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma) - Allergic to Fluorouracil or Platinum drugs; - Contraindications to MRI for any reason; - Concurrent uncontrolled medical condition; - Pregnancy or breast feeding; - Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract; - Symptoms or history of peripheral neuropathy |
Country | Name | City | State |
---|---|---|---|
China | Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Beijing |
Lead Sponsor | Collaborator |
---|---|
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
China,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | circulating tumor DNA, single cells, Cytokines and other potential biomarkers such as T-cell receptor | The exploratory end point for predicting of treatment response and survival. The circulating tumor DNA test by sequencing will includes KRAS, NRAS, BRAF,PI3K,TP53,PTEN, EGFR, NEGF etc (509-gene panel). And Measuring change in T cell receptor sub-types during treatment.Single cells test by cytof. Cytokines test by the Olink Proteomics panel. | 3-year | |
Primary | R0(microscopically margin-negative) resection and cCR rate | The composite outcome of R0 (microscopically margin-negative) resection and cCR, that is, the combined rate of radical resection and cCR management after neoadjuvant treatment. | 1-month after surgery completed | |
Secondary | local recurrence-free survival | the time from surgery to local recurrence | 3-year and 5-year | |
Secondary | distant metastasis-free survival | the time from diagnosis to metastasis | 3-year and 5-year | |
Secondary | disease-free survival | the time from surgery to recurrence | 3-year and 5-year | |
Secondary | overall survival | the time from diagnosis to death | 3-year and 5-year | |
Secondary | pathological complete response rate | pathological complete response in surgery specimen | 1-month after surgery completed | |
Secondary | clinical complete response rate | clinical complete response evaluated by MDT | 3-month after neoadjuvant treatment | |
Secondary | the acute toxicity profile | the frequency of acute adverse events during and after treatment in 1-month, including gastrointestinal (vomiting, diarrhea and incontinence), dermatitis, and hematologic toxicity evaluated weekly by the Common Terminology Criteria 4.0. | 1-month | |
Secondary | the late toxicity profile | the late toxicity after treatment completion for 1-month, the frequency of late adverse events after 1-month of treatment, including gastrointestinal function, fistula, and hematologic toxicity, evaluated regularly by LENT-SOMA scoring systems. | 3-year | |
Secondary | general quality of life (QoL) by QLQ-30 | general quality of life of patients evaluated by questionaire of EORTC QLQ-C30. The higher score in total indicates the worse quality of life in general. | 3-year | |
Secondary | QoL by QLO-CR29 | quality of life related to colorectal disease of patients evaluated by questionaire of EORTC QLQ-CR29. The higher score in total of this module indicates the worse quality of life by colorectal module. | 3-year | |
Secondary | Sum of sustained clinical complete response rate and R0 resection rate | the rate of sustained clinical complete response plus rate of R0 resection | 12 months after neoadjuvant therapy |
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