Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer

Locally Advanced Malignant Neoplasm Clinical Trial

Official title:

Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01871363
• Other study ID #: CH-GI-027
• Status: Recruiting
• Phase: Phase 2
• First received: May 19, 2013
• Last updated: June 3, 2013
• Start date: October 2012

Study information

• Verified date: June 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Jin, professor
• Phone: 87788280
• Email: jingjin1025[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Malignant Neoplasm
• Neoplasms

Intervention

Radiation:
• chemoradiation
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.

Locations

Country	Name	City	State
China	Cancer Hospital, CAMS	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease-free survival	Followup will be done every 3 months in first 2 years, and every 6 months after 2 years.	3 year afte concurrent chemoradiation	No
Primary	Pathological complete remission rate (pCR)	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)	after pathological examination of surgical speciments (6-8 weeks after chemoradiation)	No
Secondary	Acute and late toxicity	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.	Toxicity/safety:during preoperative treatment, early and late postoperative follow up	Yes