Short-course radiotherapy followed by chemotherapy for rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.