Locally Advanced Malignant Neoplasm
Conditions
Keywords
Preoperative Chemoradiotherapy, Bevacizumab, Locally Advanced Rectal Cancer
Brief summary
Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.
Interventions
RADIATIONchemoradiation
* radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel. * capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends), * bevacizumab: at dose 5 mg/kg on days -1, 15, 31. * Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients with histologically proven adenocarcinoma of the rectum ,T3/4 or any node positive disease (clinical stage according the TNM classification system) * No evidence of metastatic disease. * Age 18 - 65 years * Kps 80-100 * No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer * Normal hematological, hepatic and renal function, Ability to swallow tablets * Signed informed consent * Patients must be willing and able to comply with the protocol for duration of the study
Exclusion criteria
* Malignancy of the rectum other than adenocarcinoma * Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin * Significant heart disease (uncontrolled hypertension despite of medication (\> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment) * Evidence of active peptic ulcer or upper GI bleeding * Evidence of bleeding diathesis or coagulopathy * Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucitosine, phenytoin, or warfarin * Known hypersensitivity to biological drugs * Treatment with any investigational drug within 30 days before beginning treatment with the study drug * Pregnant or lactating patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete remission rate (pCR) | after pathological examination of surgical speciments (6-8 weeks after chemoradiation) | A TME surgery will be done 6-8 weeks after concurrent chemoradiation, pathological examination of surgical speciments will be show Pathological complete remission rate (pCR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute and late toxicity | Toxicity/safety:during preoperative treatment, early and late postoperative follow up | Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years. late toxicites will be assessed every 6 months from the third year after surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 3 year afte concurrent chemoradiation | Followup will be done every 3 months in first 2 years, and every 6 months after 2 years. |
Countries
China
Contacts
Primary ContactJing Jin, professor
Backup ContactHua Ren, attending
Outcome results
None listed