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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01871363

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Malignant Neoplasm	Radiation: chemoradiation	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: preoperative 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.	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. Other Names: Preoperative Radiotherapy With Capecitabine and Bevacizumab

Arm

Intervention/Treatment

Experimental: preoperative 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.

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.

Other Names:

Preoperative Radiotherapy With Capecitabine and Bevacizumab

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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