Neoadjuvant chemoradiotherapy and 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 clinical trial aims to compare the effectiveness of neoadjuvant chemoradiotherapy combined with consolidation chemotherapy before surgical resection against the standard treatment of neoadjuvant chemoradiotherapy followed by surgery and adjuvant chemotherapy in patients with rectal cancer. The study focuses on patients with locally advanced rectal cancer, specifically those with certain tumor characteristics. By administering both therapies preoperatively, the trial seeks to improve local control and reduce the risk of metastatic disease progression. The outcomes will be assessed to determine if this combined approach leads to better long-term survival rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed rectal adenocarcinoma
* cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1
* Multidisciplinary tumor board decision for neoadjuvant treatment
* Tumor distance from the anal verge \<15 cm based on endoscopy or magnetic resonance imaging
* Patient 18 to 80 years old
* General health condition status WHO 0-1
* Absence of co-morbidities that may affect treatment
* Neutrophils \>1,500 / mm3, platelets \>100,000 / mm3, hemoglobin\> 10 g / dL, normal creatinine, and creatinine clearance\> 50 mL / min
* Signed informed consent of the patient

Exclusion Criteria:

* Distant metastases
* Non-resectable cancer
* Contraindications for the administration of chemotherapy
* Previous pelvic radiotherapy or chemotherapy
* History of inflammatory bowel disorders
* History of angina, acute myocardial infarction or heart failure
* Active sepsis or systemic infection
* Untreated physical and mental disability
* Synchronous malignancy
* Pregnancy or breast-feeding
* Lack of compliance with the protocol process
* Non-granting of signed informed consent

Where it's running

• Department of Surgery, University Hospital of Larissa
  Larissa, Greece Recruiting

Study contacts

• Principal investigator: Konstantinos Perivoliotis, MD — University Hospital of Larissa
• Study coordinator: Konstantinos Perivoliotis, MD
• Email: kperi19@gmail.com
• Phone: 2413501000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.