Neoadjuvant Chemoradiation With Bevacizumab for Chinese Rectal Cancer Patients (New Beat)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01554059
First received: March 11, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

The purpose of the study is to evaluate the efficacy and safety of the combination of cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy as neoadjuvant treatment for patients with locally advanced but resectable rectal adenocarcinoma.


Condition Intervention Phase
Rectal Adenocarcinoma
Drug: Bevacizumab
Drug: Oxaliplatin
Drug: 5-FU
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Chemoradiation With Bevacizumab for Chinese Locally Advanced Rectal Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Sixth Affiliated Hospital, Sun Yat-sen University:

Primary Outcome Measures:
  • Pathological complete response rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Time to relapse [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Safety data of this regimen [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: March 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    Bevacizumab 5mg/m2 D1,D15,D29,D43;
    Other Name: Avastin
    Drug: Oxaliplatin
    Oxaliplatin 85mg/m2 D1,D57; Oxaliplatin 85mg/m2 biweekly * 6 doses 3-4 weeks after radical resection
    Drug: 5-FU
    5-FU 2800mg/m2 civ 48 hours D1,D57; 5-FU 2800mg/m2 civ 48 hours biweekly*6 doses 3-4 weeks after radical resection; 5-FU 200mg/m2/day civ D15-19,D22-26,D29-33,D36-40,D43-47;
    Radiation: Radiotherapy
    2GY daily *20次
Detailed Description:

Primary endpoint: Pathological Complete Response Rate (pCR)

Secondary endpoint: Time to Relapse, disease free survival, overall survival and safety data

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG status of 0 or 1.
  • All patients must have histologically confirmed adenocarcinoma of the rectum. The clinical stage must be T3, T4, or regional lymphnode involvement based on CT, MRI or EUS criteria. Criteria for pathologic enlargement of lymph nodes is > 15 mm on short axis dimension. If CT findings of lung, liver, or peritoneal metastases are equivocal, patients are eligible to participate.
  • All patients must have no distant metastatic disease on abdominopelvic CT scan performed with IV contrast.
  • The rectal tumor must be either palpable on digital rectal exam or the inferior edge of the tumor must be within 12 cm of the anal verge based on rigid proctoscopy.
  • Patients must have WBC > 4*10E9/L, ANC of > 1.5 *10E9/L, platelets > 100*10E9/L, Hemoglobin of > 90 g/L and adequate hepatic and renal function.
  • Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.

Exclusion Criteria:

  • Known compromised renal or hepatic function.
  • Participation in any other experimental drug study.
  • AST or ALT > 5 times upper limit of normal for subjects with documented liver metastases; > 2.5 times the upper limit of normal for subjects without evidence of liver metastases.
  • Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman/men of childbearing potential not using a reliable contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 30 days from the date of the last study drug administration.
  • Any prior chemotherapy.
  • Any prior radiation therapy.
  • Serious, uncontrolled, concurrent infection(s) requiring IV antibiotics.
  • Treatment for other carcinomas within the last five years, except cure non-melanoma skin cancer and treated in-situ cervical cancer.
  • Clinically significant cardiac disease (e.g., uncontrolled hypertension [blood pressure of > 160/110 mmHg on medication], any history of myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix H), unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or grade II or greater peripheral vascular disease(see Appendix H).
  • Evidence of bleeding diathesis or coagulopathy, INR greater than or equal to 1.5.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0.
  • Proteinuria at baseline or clinically significant impairment of renal function Subjects unexpectedly discovered to have 1+ proteinuria at baseline should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 500 mg of protein/24 hr to allow participation in the study.
  • Currently has serious, nonhealing wound, ulcer, or bone fracture.
  • Had aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations within the past year.
  • Patients who have had an organ allograft.
  • Patients taking cimetidine must have this drug discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary. If patient is currently receiving allopurinol, must discuss with PI to see of another agent may substitute for it.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554059

Contacts
Contact: Yue Cai, Master 86-20-38250745 chilly8518@163.com

Locations
China, Guangdong
Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510600
Contact: Yue Cai, Master    86-20-38250745    chilly8518@163.com   
Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Yue Cai, Master    86-20-38250745    chilly8518@163.com   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Jian Xiao, Principal Investigator, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01554059     History of Changes
Other Study ID Numbers: SAHMO-03
Study First Received: March 11, 2012
Last Updated: March 27, 2012
Health Authority: China: Ethics Committee

Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:
Rectal cancer
Adenocarcinoma
Bevacizumab
Chemoradiation

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014