Rectal Cancer
Conditions
Keywords
cetuximab, capecitabine, radiotherapy, rectal cancer
Brief summary
This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectable rectal cancers.
Detailed description
Preoperative radiotherapy and 5-FU based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.Capecitabine has the potential to replace 5-FU as standard agent. Cetuximab is a monoclonal antibody directed against EGFR. Both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.The trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage II and III rectal cancer.
Interventions
Cetuximab 400mg/m2 in iv infusion as an initial dose on day 15, then a weekly dose of 250mg/m2 for 5 weeks during radiotherapy (days 22, 29, 36, 43, 50). Capecitabine: 1250 mg/m² bd for 14 days (1 cycle); 825mg/m2 bd over 5 weeks during radiotherapy. Radiotherapy: planned total dose of 45 Gy in 25 fractions using a four-field plan in 5 weeks.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 80 if judged fit for surgery * WHO performance status 0-1 * Histologically proven rectal adenocarcinoma located below the peritoneum * T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI * No distant metastases * Adequate haematological, cardiac, liver and renal function * Signed informed consent * Appropriate measures for contraception for men and women, if applicable
Exclusion criteria
* Prior radio- and/or chemotherapy * Others synchronous cancers * History of other malignant disease * Significant heart disease * Known hypersensitivity to biological drugs * Pregnant or lactating patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pathological remission rate | at pathological examm of surgical speciment |
Secondary
| Measure | Time frame |
|---|---|
| Rate of sphincter sparing surgical procedure Toxicity/safety | Toxicity/safety:during preoperative treatment, early and late postoperative follow up |
Countries
Slovenia
Outcome results
None listed