Status:
RECRUITING
Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Radiation Oncology
Rectal Cancer
Eligibility:
All Genders
18-70 years
Brief Summary
Preoperative radiotherapy followed by total mesorectal excision (TME) has been recommended as the preferred treatment method for locally advanced rectal cancer. Similar rates of local control, surviva...
Detailed Description
Rectal cancer is one of the most common malignant tumors in western countries and its incidence and mortality rates have been ascending for several decades in our country. Surgical resection is the pr...
Eligibility Criteria
Inclusion
- Previously untreated, biopsy-proven stage T3-4 and/or N+，resectable rectal adenocarcinoma with the tumors near anal verge within 12 cm;
- Male or non-pregnant female;
- Between 18 and 70 years of age;
- Adequate hematologic function: white blood cell(WBC) counts≥4,000/mm3, neutrophils counts ≥ 1,500/mm3, platelet counts ≥ 100,000/µL, hemoglobin ≥ 9g/L;
- Adequate renal function: creatinine ≤ 1.5×upper normal limit;
- Adequate hepatic function: total bilirubin, glutamic oxalacetic transaminase, glutamate pyruvate transaminase level \< 2.0×upper normal limit);
- Satisfactory performance status: Karnofsky Performance Status(KPS)≥70;
- Approval from the ethics committee and prior written informed consents from all patients before registration were obtained.
Exclusion
- the evidence of relapse or distant metastasis;
- receiving treatment of other anti-cancer drugs or methods;
- Patients have low compliance and are not able to complete the entire trial;
- the presence of uncontrolled life-threatening diseases;
- dysfunction of heart, brain, lung and et al.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03466424
Start Date
August 1 2022
End Date
December 1 2026
Last Update
February 16 2023
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000