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

NCT01871363 | Unknown Phase 2

• 1 other identifier: CH-GI-027
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Malignant Neoplasm

Keywords

Preoperative Chemoradiotherapy; Bevacizumab; Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Acute and late toxicity

  Toxicity/safety:during preoperative treatment, early and late postoperative follow up

Other Outcomes (1)

• Disease-free survival

  3 year afte concurrent chemoradiation

Study Arms (1)

preoperative chemoradiation

EXPERIMENTAL

* 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

Interventions

chemoradiation RADIATION

* 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.

Also known as: Preoperative Radiotherapy With Capecitabine and Bevacizumab

preoperative chemoradiation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, CAMS

Beijing, 100021, China

RECRUITING

MeSH Terms

Interventions

Chemoradiotherapy; Capecitabine; Bevacizumab

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jing Jin, proffessor

  Dept of Radiation oncology, Cancer hospital, CAMS

  STUDY CHAIR

Central Study Contacts

Jing Jin, professor

CONTACT

87788280; jingjin1025@163.com

Hua Ren, attending

CONTACT

87788122; renhua2009@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Radiation oncologist

Study Record Dates

• First Submitted: May 19, 2013
• First Posted: June 6, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Last Updated: June 6, 2013

Record last verified: 2013-06

Locations

CN (1)