Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Magnetic resonance guided radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1. Cohort 2
- description
- A total of 6 courses of oxaliplatin plus capecitabine chemotherapy and 2 courses of capecitabine single drug chemotherapy were performed. Concurrent chemoradiotherapy starts at the second cycle. Cohort 1: For patients with low rectal cancer who refused surgery before the initial diagnosis and treatment, the first stage of radiotherapy used conventional linear accelerated radiotherapy, with doses of GTV 50Gy/25f and CTV 45Gy/25f for 5-6 weeks. Subsequently, the second stage of radiotherapy boost was continued with MR linear accelerator, and the dose was GTV 16\~20Gy/8\~10f for 2 weeks. Cohort 2: For locally advanced low rectal cancer patients who did not achieve clinical complete remission 6-8 weeks after neoadjuvant radiochemotherapy and refused surgery, radiotherapy was given in the first stage at the doses of GTV 50Gy/25f and CTV 45Gy/25f for 5-6 weeks. In the second stage, MR linear accelerator was used for radiotherapy boosting, and the dose was GTV 30Gy/15f for 3 weeks.
- interventionNames
- Radiation: Magnetic resonance guided radiotherapy
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- 3-year progression free survival rate
- timeFrame
- 3-year after enrollment
- description
- Percentage of survive patients with no disease progression or death after 3 years from enrollment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed as rectal adenocarcinoma. 2. MRI and / or electronic colonoscopy confirmed that the lower edge of the tumor was ≤ 5cm from the anal edge. 3. The AJCC clinical stage was cT1-4NxM0, with or without MRF positive and EMVI positive. 4. MSI gene detection or MMR protein immunohistochemical detection was MSS / PMMR. 5. No obvious signs of intestinal obstruction or intestinal obstruction has been relieved after proximal colostomy. 6. Age: 18 \~ 80 years old. 7. ECOG score: 0-1. 8. Expected life: more than 3 years. 9. Hematology: WBC \> 3 × 109/L; PLT\>80 × 109/L; Hb\>90g/L. 10. Liver function: ALT and AST were less than 2 times of normal value; Bilirubin is less than 1.5 times of normal value. 11. Renal function: creatinine is less than 1.5 times of normal value or creatinine clearance rate (CCR) ≥ 60ml / min. 12. Patient who has not received tumor resection, radiotherapy, chemotherapy, immunotherapy or other anti-tumor treatment. Exclusion Criteria: 1. There are any conditions that make MRI impossible. 2. There are serious medical complications. 3. Uncontrolled infectious diseases, autoimmune diseases and mental diseases. 4. Any unstable condition or situation that may endanger patient safety and compliance. 5. Pregnant or lactating women who are fertile and do not take adequate contraceptive measures. 6. Refuse to sign informed consent.
References
Publications (24)
- BACKGROUNDWang Q, Zhang S, Zhou C, et al. Efficacy and safety of high dose radiotherapy for the treatment of locally advanced rectal cancer. International Journal of Radiation Oncology Biology Physics. 2020. 108(3): e644-e645
- RESULTTorre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. PMID 25651787
- RESULTGlimelius B, Tiret E, Cervantes A, Arnold D; ESMO Guidelines Working Group. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi81-8. doi: 10.1093/annonc/mdt240. No abstract available. PMID 24078665
- RESULTGalandiuk S, Wieand HS, Moertel CG, Cha SS, Fitzgibbons RJ Jr, Pemberton JH, Wolff BG. Patterns of recurrence after curative resection of carcinoma of the colon and rectum. Surg Gynecol Obstet. 1992 Jan;174(1):27-32. PMID 1729745
- RESULTSebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20. doi: 10.1016/S0140-6736(09)60484-0. PMID 19269519
- RESULTHeald RJ, Ryall R. Recurrent cancer after restorative resection of the rectum. Br Med J (Clin Res Ed). 1982 Mar 13;284(6318):826-7. doi: 10.1136/bmj.284.6318.826-e. No abstract available. PMID 6802248
- RESULTSauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.