Short-course radiotherapy followed by chemotherapy for 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
This study is testing whether a short course of radiation followed by chemotherapy can help people with locally advanced rectal cancer respond better to treatment before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT03466424 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of preoperative short-course radiotherapy followed by neo-adjuvant chemotherapy in patients with locally advanced rectal cancer. It aims to explore the optimal treatment regimen by comparing different doses of short-course radiotherapy and their impact on pathological complete response rates. The study includes patients with biopsy-proven resectable rectal adenocarcinoma and evaluates their outcomes after receiving the treatment. The approach seeks to improve local control and reduce treatment intervals while maintaining safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates are previously untreated adults aged 18 to 70 with biopsy-proven stage T3-4 and/or N+ resectable rectal adenocarcinoma.
Not a fit: Patients with evidence of relapse or distant metastasis, or those receiving other anti-cancer treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the rates of pathological complete response in patients with locally advanced rectal cancer.
How similar studies have performed: Previous studies have shown that short-course radiotherapy followed by chemotherapy can improve outcomes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Benhua Xu — Fujian Medical University Union Hospital
- Study coordinator: Benhua Xu
- Email: benhuaxu@163.com
- Phone: 86+13696884375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.