NCT05338866Enrolling by invitation
Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using MR Guided Linear Accelerator
Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using Magnetic Resonance Guided Radiotherapy Linear Accelerator：A Prospective Phase 2 Trial
Source: ClinicalTrials.gov · Last updated 22 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The incidence rate of colorectal cancer is third in male tumors and second in female tumors. The newly diagnosed incidence of colorectal cancer is no less than 100 thousand in China, which poses a great threat to people's health and a heavy burden of public health. Preoperative neoadjuvant radiotherapy and chemotherapy combined with radical surgery is recommended for locally advanced rectal cancer. Low rectal cancer accounts for about one third of all rectal cancer cases. Due to the particularity of its location，surgical complications and postoperative patients need permanent colostomy (artificial anus) to solve the defecation problems, which has a serious impact on the patients' work and life. How to improve the quality of life of patients without reducing the survival rate has become an important topic in the treatment of low rectal cancer. Previous studies have shown that the prognosis of patients with pathological complete remission (pCR) after neoadjuvant chemoradiotherapy for rectal cancer is optimistic. The clinical efficacy of "observation and waiting" is good. The results of small sample exploratory clinical studies of radical radiotherapy and chemotherapy for low rectal cancer are satisfactory, and MR-linear accelerator can be used for precision radiotherapy for colorectal cancer. This study is aimed to explore the efficacy and safety of radical radiotherapy boost for low rectal cancer by using magnetic resonance guided radiotherapy system, and further evaluate the impact of boost on the quality of life of patients.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 58 (estimated)
- First submitted
- 5 Apr 2022
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT05338866
What you commit to
- Study type: Observational
- Planned participants: 58
- From 1 Jan 2022 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- There are any conditions that make MRI impossible.
- Uncontrolled infectious diseases, autoimmune diseases and mental diseases.
- Any unstable condition or situation that may endanger patient safety and compliance.
Other
- There are serious medical complications.
- Pregnant or lactating women who are fertile and do not take adequate contraceptive measures.
- Refuse to sign informed consent.
Who the study is looking for
- Histologically confirmed as rectal adenocarcinoma.
- MRI and / or electronic colonoscopy confirmed that the lower edge of the tumor was ≤ 5cm from the anal edge.
- The AJCC clinical stage was cT1-4NxM0, with or without MRF positive and EMVI positive.
- MSI gene detection or MMR protein immunohistochemical detection was MSS / PMMR.
- No obvious signs of intestinal obstruction or intestinal obstruction has been relieved after proximal colostomy.
- Age: 18 \~ 80 years old.
- ECOG score: 0-1.
- Expected life: more than 3 years.
- Hematology: WBC \> 3 × 109/L; PLT\>80 × 109/L; Hb\>90g/L.
- Liver function: ALT and AST were less than 2 times of normal value; Bilirubin is less than 1.5 times of normal value.
- Renal function: creatinine is less than 1.5 times of normal value or creatinine clearance rate (CCR) ≥ 60ml / min.
- Patient who has not received tumor resection, radiotherapy, chemotherapy, immunotherapy or other anti-tumor treatment.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.