NCT03466424 Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer
| NCT ID | NCT03466424 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fujian Medical University Union Hospital |
| Condition | Radiation Oncology |
| Study Type | OBSERVATIONAL |
| Enrollment | 9 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 9 participants in total. It began in 2022-08-01 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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 Criteria
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.
Contact & Investigator
Benhua Xu
PRINCIPAL INVESTIGATOR
Fujian Medical University Union Hospital
Frequently Asked Questions
Who can join the NCT03466424 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Radiation Oncology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03466424 currently recruiting?
Yes, NCT03466424 is actively recruiting participants. Contact the research team at benhuaxu@163.com for enrollment information.
Where is the NCT03466424 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT03466424 clinical trial?
NCT03466424 is sponsored by Fujian Medical University Union Hospital. The principal investigator is Benhua Xu at Fujian Medical University Union Hospital. The trial plans to enroll 9 participants.