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

NCT03466424 · tracked via the Priya Life Science China tracker

Sponsor

Fujian Medical University Union Hospital

Phase

Observational

Started

2022-08-01

Last updated

2023-02-16

Condition(s) studied

Radiation OncologyRectal Cancer

Investigational drug(s) / intervention(s)

preoperative short-course radiotherapy

preoperative short-course radiotherapy: Patients will be enrolled into Group 1 to 3 according to the time order of entering the study to receive dose from 6Gy×5F to 8Gy×5F using the traditional 3+3 dose escalation design.

Study 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, 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 SCRT followed by mFOLFOX6 chemotherapy can improve the pCR rates. Therefore, investigators aimed to establish a dose escalation mode of SCRT (5×6Gy/7Gy/8Gy) followed by four cycles of modified FOLFOX6(mFOLFOX6) chemotherapy to test the safety and efficacy in treating locally advanced rectal cancer.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

Pathological complete response(pCR) rate — four weeks after surgery
According to pathological response criteria, a total regression is considered a complete response.

Trial sites (1)

Facility	City	Region	Status
Fujian Medical University Union Hospital	Fuzhou	Fujian	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03466424 on ClinicalTrials.gov ↗ ← All trials in China