Multicentre, open-label, randomised, controlled, parallel arms clinical trial of induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer
- Conditions
- Recurrent Rectal CancerMedDRA version: 21.0Level: PTClassification code 10038046Term: Rectal cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-002141-42-NO
- Lead Sponsor
- Catharina Ziekenhuis Eindhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 364
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 18 years or older
- Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal cancer either by histopathology or by
clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
-Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy.
(Expected gross incomplete resection with overt tumour remaining in the patient after resection, tumour invasion in the neuroforamina, encasement of the ischiadic nerve and invasion of the cortex from S3 and upwards are considered not resectable)
- WHO performance score 0-1
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation. (Patients with enlarged iliac lymph nodes, enlarged inguinal lymph nodes and aspecific lung noduli are not excluded from inclusion).
- Homozygous DPD deficiency
- Any chemotherapy in the past 6 months.
- Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction with creatinine clearance of <30ml/min, thrombocytopenia of <100x109/L), as determined by the medical oncologist.
- Radiotherapy in the past 6 months for primary rectal cancer.
- Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to chemotherapy agent, no possibility for radiotherapy due to previous radiotherapy), as determined by the medical oncologist and/or radiation oncologist.
- Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist.
- Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to determine the rate of resections with clear resection margins after treatment with induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery compared to treatment with neoadjuvant chemoradiotherapy and surgery alone.;Secondary Objective: The secondary objectives are to determine the local re-recurrence free survival, progression free survival, metastasis free survival, disease free survival, overall survival, objective radiological response, pathologic response, toxicity, surgical complications, quality of life and costs for both arms.;Primary end point(s): Proportion of patients with a clear resection margin. A resection margin is considered clear (R0), if there are no tumour cells in any of the resection surfaces as determined by microscopy (resection margin > 0mm);Timepoint(s) of evaluation of this end point: Scored within 1 one month of surgery
- Secondary Outcome Measures
Name Time Method