Trial Outcomes & Findings for Neoadjuvant Chemoradiation With RHUMAB VEGF (Avastin) for Rectal Cancer (NCT NCT00113230)

Results Overview

At follow-up evaluation after completion of neoadjuvant and surgical therapy, resected primary tumor classified based on routine pathology staining in the following manner: Pathologic Complete Response (no evidence of residual cancer); Microscopic Residual (no grossly detected disease, but evidence of microscopic residual disease); and Gross Residual Disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Baseline to approximately 5 Months (Following 28 days of treatment, chemotherapy and surgical resection of tumor)

Results posted on

2012-08-07

Participant Flow

Recruitment Period: 4/21/05 through 8/31/07. All participants recruited at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Avastin Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Chemoradiation With RHUMAB VEGF (Avastin) for Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avastin n=25 Participants Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
Age Continuous	51 years n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Region of Enrollment United States	25 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to approximately 5 Months (Following 28 days of treatment, chemotherapy and surgical resection of tumor)

Population: Intention to treat analysis method. Data examination conducted upon enrollment and evaluability of 25 patients.

At follow-up evaluation after completion of neoadjuvant and surgical therapy, resected primary tumor classified based on routine pathology staining in the following manner: Pathologic Complete Response (no evidence of residual cancer); Microscopic Residual (no grossly detected disease, but evidence of microscopic residual disease); and Gross Residual Disease.

Outcome measures

Outcome measures
Measure	Avastin n=25 Participants Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
Pathologic Local Tumor Response Pathological Complete Response	8 Participants
Pathologic Local Tumor Response Microscopic Residual (<10% viable tumor cells)	6 Participants
Pathologic Local Tumor Response Gross Residual Disease	11 Participants

Adverse Events

Avastin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Avastin n=25 participants at risk Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
Blood and lymphatic system disorders Amyloidosis	4.0% 1/25 • Number of events 1 • 2 Years

Additional Information

Christopher H. Crane, MD / Associate Professor

UT MD Anderson Cancer Center

Phone: 713-792-2933

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place