CAPECITABINE for Rectal cancer

Inclusion criteria

• {"criterion_text":"- The subject has given their written consent to participate in the trial\n- Be 18 years or older\n- Have an adenocarcinoma verified tumour within the rectum below 12 cm from anal verge\n- Have a tumour stage of TX/T1-3b (regardless of tumour size)\n- Have no nodal metastases (NX/N0)\n- Have no distant metastases (MX/M0)\n- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n- For female subjects of childbearing potential: Have a negative pregnancy test within 7 days prior to study entry and Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment\n- If non-sterilised male with a partner of childbearing potential, must: Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment"}

Exclusion criteria

• {"criterion_text":"- Give no informed consent\n- Have no residual luminal tumour following endoscopic resection prior to first visit at surgical department\n- Have contraindications to radiotherapy including previous pelvic radiotherapy\n- Have uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)\n- Have known complete dihydropyrimidine dehydrogenase (DPYD) deficiency\n- Have known Gilbert’s disease (hyperbilirubinemia)\n- Have been taking coumarin-derivative anticoagulants (e.g. warfarin) that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin\n- Are taking metronidazole, phenytoin or sorivudine or its chemically related analogues, such as brivudine, within 4 weeks of trial entry (see Section 8.3.5 for further details)\n- Are Pregnant or lactating woman\n- Have history of severe and unexpected reactions to fluoropyrimidine therapy\n- No biopsy confirmed rectal cancer (adenocarcinoma)\n- Have a recurrent rectal cancer\n- An age below 18\n- Have concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse within 3 years or lead to death within 5 years\n- Have unequivocal evidence of metastatic disease (includes respectable metastases)(Patients with equivocal radiological lesions (e.g. retroperitoneal, liver, lung) that are not classified as M1 are eligible if agreed by MDT)\n- Have an MRI node positive tumour (≥N1, defined by protocol guidelines) (Patients with equivocal radiological findings that are either classified as NX or N0 are eligible)\n- Have MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines)\n- Have a threatened mesorectal fascia (≤1 mm on MRI or ERUS)"}

Primary endpoints

• {"endpoint_text":"- Ratio of patients with a non-operative approach at onset that after evaluation by a combination of MRI, clinical and endoscopic examination have a clinical complete response at 1 year.","definition_or_measurement_approach":"Clinical complete response assessed at 1 year after treatment by a combination of MRI, clinical and endoscopic examination."}

Secondary endpoints

• {"endpoint_text":"- Local recurrence","definition_or_measurement_approach":""}
• {"endpoint_text":"- Local regrowth","definition_or_measurement_approach":""}
• {"endpoint_text":"- Survival (overall)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Metastases","definition_or_measurement_approach":""}
• {"endpoint_text":"- Organ preservation rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Clinical complete response rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Morbidity measured with Comprehensive Complications Classification Index (41)","definition_or_measurement_approach":"Morbidity measured using the Comprehensive Complications Classification Index."}
• {"endpoint_text":"- Total length of hospital stay","definition_or_measurement_approach":""}
• {"endpoint_text":"- Radical resection (R0) after surgery","definition_or_measurement_approach":""}
• {"endpoint_text":"- Urinary function","definition_or_measurement_approach":""}
• {"endpoint_text":"- Sexual function","definition_or_measurement_approach":""}
• {"endpoint_text":"- Bowel function","definition_or_measurement_approach":""}
• {"endpoint_text":"- Presence of a stoma","definition_or_measurement_approach":""}

Sweden

Earliest CTIS Part Ii Submission Date

19-12-2025

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

138

Number Of Sites

3

Number Of Participants

80

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden