Clinical trial NCT01871363: Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
Official title: Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Malignant Neoplasm
Keywords: Preoperative Chemoradiotherapy
Bevacizumab
Locally Advanced Rectal Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2013-06-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pathological complete remission rate (pCR)
timeFrame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
Secondary outcomes:
measure: Acute and late toxicity
timeFrame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up
Other outcomes:
measure: Disease-free survival
timeFrame: 3 year afte concurrent chemoradiation
Locations:
city: Beijing
country: China
facility: Cancer Hospital, CAMS
Study officials:
affiliation: Dept of Radiation oncology, Cancer hospital, CAMS
name: Jing Jin, proffessor
role: STUDY_CHAIR
References: