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Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer

Recruitingn/aAges 18 Years - 70 YearsAllFujian Medical University Union Hospital
NCT03466424 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, survival and toxicity were observed in preoperative long-course radiotherapy (LCRT) (45-50.4 Gy in 25-28 fractions) and short-course radiotherapy (SCRT) of 25 Gy in five fractions. For the convenience of SCRT, a growing number of patients tend to receive SCRT as preoperative radiotherapy. Although SCRT can shorten treatment interval and cut down the cost of treatment, it's pathological complete response (pCR) rate is relatively low (SCRT vs. LCRT: 0.7% vs. 16%). Hence, the optimal pattern of preoperative therapy of locally advanced rectal cancer still deserves to be explored. Previous studies have confirmed the feasibility and safety of 30Gy/5 fractions in SCRT of rectal cancer and verified that SC

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • preoperative short-course radiotherapy
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Where

1 site
Fujian Medical University Union Hospital
Fuzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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