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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Locally Advanced Malignant Neoplasm

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathological complete remission rate (pCR)

Outcome Description:

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)

Outcome Time Frame:

after pathological examination of surgical speciments (6-8 weeks after chemoradiation)

Safety Issue:

No

Principal Investigator

Jing Jin, proffessor

Investigator Role:

Study Chair

Investigator Affiliation:

Dept of Radiation oncology, Cancer hospital, CAMS

Authority:

China: Food and Drug Administration

Study ID:

CH-GI-027

NCT ID:

NCT01871363

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Locally Advanced Malignant Neoplasm
  • Preoperative Chemoradiotherapy
  • Bevacizumab
  • Locally Advanced Rectal Cancer
  • Neoplasms
  • Rectal Neoplasms

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