Induction chemotherapy for locally advanced rectal cancer.

Phase 1

• Conditions: High risk locally advanced rectal cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003134-20-NL
• Lead Sponsor: Catharina Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-18
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

- 18 years or older
- Histopathologically confirmed rectal cancer.
- Confirmed high-risk locally advanced rectal cancer, meeting the following imaging based criteria:
oTumour invasion of mesorectal fascia (MRF)
oThe presence of grade 4 extramural venous invasion (mrEMVI)
oThe presence of tumour deposits
oThe presence of Extramesorectal lymph nodes with a short-axis size > 7mm
- Resectable disease as determined on magnetic resonance imaging (MRI) or deemed resectable disease after neoadjuvant treatment.
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) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

- Evidence of metastatic disease at the moment of randomisation or within six months prior to randomisation except for patients with enlarged iliac or inguinal lymph nodes and aspecific lung noduli.
- Homozygous DPD deficiency
- Any chemotherapy within the past 6 months
- Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction and thrombocytopenia), as determined by the medical oncologist.
- Radiotherapy in the pelvic area within the past 6 months.
- Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to the chemotherapy agent or no possibility to receive radiotherapy), as determined by the medical oncologist and/or radiation oncologist.
- Any contraindication to undergo surgery, as determined by the surgeon and/or anaesthesiologist.
- Concurrent malignancies that interfere with the planned study treatment or the prognosis of the resected tumour.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified