Middle-lower Locally Advanced Rectal Cancer
Conditions
Interventions
Experimental group:patients receive 1cycle of XELOX before concurrent capecitabine-based modified short-course radiotherapy, and after msCRT, another 3 cycles of XELOX as neoadjuvant chemotherapy woul
control group:concurrent capecitabine-based long-course radiotherapy, TME surgery and 4 cycles of XELOX as adjuvant chemotherapy.
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years. Karnofsky Performance Scores(KPS) =70Eastern Collaborative Oncology Group performance status score =2; 2. Histologically confirmed rectal adenocarcinoma (tubular adenocarcinoma); 3. Distance between tumour and anal verge= 8cm on Magnetic resonance imaging (MRI) and/or rigid sigmoidoscopy; tumor occupying the range of circumference of the bowel =2/3. High risk of rectal cancer defined by high-resolution MRI, include the following four sub-groups: (1) cT3c/d or very low localisation levators threatened, MRF clear; (2) cT3c/d mid-rectum, cN1–N2 (extranodal), EMVI+, limited cT4aN0; (3) cT3 with any MRF involved; (4) any cT4a/b, lateral node+; 4. All patitents had no history of radiotherapy or chemotherapy; 5. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: (1) Leukocytes = 3.0 x10^9/L, absolute neutrophil count (ANC) = 1.5 x10^9/L, platelet count = 80 x10^9/L, hemoglobin (Hb) = 9g/dL; (2) Total bilirubin =1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 x ULN. Serum creatinine = 1 x the ULN. Calculated creatinine clearance or 24 hour creatinine clearance = 50 mL/ min (Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Other malignancies, non tubular adenocarcinoma rectal malignancies , such as mucinous adenocarcinoma, signet ring cell carcinoma, squamous cell carcinoma, adenoid squamous cell carcinoma, medullary carcinoma, undifferentiated carcinoma; 2. Karnofsky Performance Scores(KPS) 2. 3. With distant metastasis. 4. Combined with severe diseases of medical comorbiditiesdysfunction of multiple organs (cardioncerebral vascular system, respiratiory system, liver, kidney)or combined with severe mental diseases; 5. Patitents that had history of other malignancy; 6. patitents that had history of radiotherapy or chemotherapy; 7. patitents that had history of biological target therapy or who are intended to be treated with biological target therapy; 8. Patients with a history of addiction and abuse; 9. History of immune deficiency including patients testing positive for HIV, or with genetic immunodeficiency disease, or with organ transplantation; 10. Patients who are in the period of acute and chronic tuberculosis infection (T-spot test positive, chest X-ray suspicious tuberculosis); 11. Pregnant or lactating women; 12. Participators who had been recruited by other clinical trial within three months; 13. researchers think it is not appropriate to participate in the experimenter. For example, patients who can not tolerate the treatment. 14. Contraindications to MRI or CT enhancement scan for any reason; 15. tumor occupying the range of circumference of the bowel >2/3 or rectal obstruction; 16. Patients with active massive gastrointestinal bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| downstaging rate of T-stage; | — |
Secondary
| Measure | Time frame |
|---|---|
| tumor regression grade, TRG;Pathological complete response rate;R0 of total mesorectal excision rate;three-year disease-free survival rate;three-year overall survival rate;three-year local recurrence rate;quality of life;adverse events; | — |
Countries
China
Contacts
Public ContactTuhua Li
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed