Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer
Phase I Trial of Dose-escalation Preoperative Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy in Locally Advanced Rectal Cancer : the FJUHR-01 Trial
1 other identifier
observational
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedFebruary 16, 2023
February 1, 2023
2.8 years
February 28, 2018
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological complete response(pCR) rate
According to pathological response criteria, a total regression is considered a complete response.
four weeks after surgery
Secondary Outcomes (4)
R0 resection rate
four weeks after surgery
Sphincter preservation rate
four weeks after surgery
Incidence of surgical complications
four weeks after surgery
Incidence of acute toxicities during radiation or chemotherapy
three months
Study Arms (3)
Group 1
preoperative short-course radiotherapy(5×6Gy) followed by 4×mFOLFOX6 chemotherapy
Group 2
preoperative short-course radiotherapy(5×7Gy) followed by 4×mFOLFOX6 chemotherapy
Group 3
preoperative short-course radiotherapy(5×8Gy) followed by 4×mFOLFOX6 chemotherapy
Interventions
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.
Eligibility Criteria
Hosptal in-patients
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Related Publications (1)
Zhang MX, Li XB, Guan BJ, Guan GX, Lin XY, Wu XD, Chi P, Xu BH. Dose escalation of preoperative short-course radiotherapy followed by neoadjuvant chemotherapy in locally advanced rectal cancer: protocol for an open-label, single-centre, phase I clinical trial. BMJ Open. 2019 Mar 23;9(3):e025944. doi: 10.1136/bmjopen-2018-025944.
PMID: 30904869DERIVED
Biospecimen
whole blood, tumor tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benhua Xu
Fujian Medical University Union Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director,Radiation Oncology
Study Record Dates
First Submitted
February 28, 2018
First Posted
March 15, 2018
Study Start
August 1, 2022
Primary Completion
June 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
February 16, 2023
Record last verified: 2023-02