Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer
|ClinicalTrials.gov Identifier: NCT00321685|
Recruitment Status : Active, not recruiting
First Posted : May 4, 2006
Results First Posted : May 12, 2015
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rectal Adenocarcinoma Stage II Rectal Cancer AJCC v7 Stage III Rectal Cancer AJCC v7||Biological: Bevacizumab Drug: Capecitabine Drug: Fluorouracil Drug: Leucovorin Calcium Drug: Oxaliplatin Radiation: Radiation Therapy Procedure: Therapeutic Conventional Surgery||Phase 2|
I. To evaluate the pathological complete response rate in patients with T3 and T4 rectal cancers when treated preoperatively with capecitabine, oxaliplatin, bevacizumab, and concurrent radiotherapy (XRT).
II. To evaluate the resection rate for T3 and T4 rectal cancers and the expected versus actual type of resection (abdominoperinal resection [APR] vs. low anterior resection [LAR] vs. LAR/coloanal anastomosis).
III. To make preliminary observations of patient survival and patterns of recurrence for this treatment combination.
IV. To gain additional experience regarding the toxicity and tolerability of this preoperative and postoperative regimen.
PREOPERATIVE CHEMORADIOTHERAPY: Patients undergo radiotherapy (total dose to the tumor bed was 5040 cGy) once daily (QD) 5 days a week and receive capecitabine 825 mg/m^2 orally (PO) twice daily (BID) 5 days a week for 5.5 weeks. Patients also receive oxaliplatin 50 mg/m^2 intravenously (IV) over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab 5 mg/kg IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
SURGERY: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection. Patients whose tumors are not completely resected or who have metastatic disease discontinue protocol therapy.
POSTOPERATIVE CHEMOTHERAPY: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium 400 mg/m^2 IV over 2 hours, and bevacizumab 5 mg/kg IV over 30-90 minutes on day 1. Patients also receive fluorouracil 2400 mg/m^2 IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Patients then receive up to 3 additional courses of leucovorin calcium, fluorouracil, and bevacizumab.
After completion of study treatment, patients are followed up periodically for 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX) and Bevacizumab in Patients With Locally Advanced Rectal Cancer|
|Actual Study Start Date :||July 25, 2006|
|Actual Primary Completion Date :||August 12, 2013|
|Estimated Study Completion Date :||May 1, 2020|
Experimental: Treatment (bevacizumab and chemoradiotherapy)
See Detailed Description
Drug: Leucovorin Calcium
Radiation: Radiation Therapy
Procedure: Therapeutic Conventional Surgery
Undergo surgical resection
- Pathologic Complete Response Rate [ Time Frame: Assessed at surgery time ]Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients
- Resection Rate for T3 Rectal Cancers [ Time Frame: Assessed at surgery time ]Resection rate is defined as number of patients with T3 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T3 rectal cancers
- Resection Rate for T4 Rectal Cancers [ Time Frame: Assessed at surgery time ]Resection rate is defined as number of patients with T4 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T4 rectal cancers
- 5-year Overall Survival Rate [ Time Frame: survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration ]Overall survival is defined as time from registration to death from any cause. 5-year overall survival rate is estimated using Kaplan-Meier method.
- 5-year Recurrence-free Survival Rate [ Time Frame: recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration ]Recurrence free survival is defined as time from surgery to disease recurrence or death without recurrence (whichever occurred first) among resected patients. 5-year recurrence-free survival rate is estimated using Kaplan-Meier method, with 90% confidence interval calculated using Greenwood's formula.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321685
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|Principal Investigator:||Jerome Landry||ECOG-ACRIN Cancer Research Group|