NCT00408694|CompletedPhase 2Results

Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer

A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

Compare

5 other identifiers

NCI-2009-00736RTOG-0615CDR0000518526RTOG 0615U10CA021661

Study Type

interventional

Target

Locations

2 countries

Sites

108

Timeline

RegisteredDec 2006

StartedDec 2006

CompletionDec 2011

Brief Summary

This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with chemotherapy and radiation therapy may kill more tumor cells.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Dec 2006

Longer than P75 for phase_2

Geographic Reach

2 countries

108 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

First Submitted

Initial submission to the registry

December 6, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2006

Completed

6 days until next milestone

Study Start

First participant enrolled

December 13, 2006

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2011

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

April 18, 2013

Completed

Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

5 years

First QC Date

December 6, 2006

Results QC Date

March 1, 2013

Last Update Submit

January 4, 2018

Conditions

Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7 Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7

Outcome Measures

Primary Outcomes (1)

Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.
Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
From start of treatment to one year.

Secondary Outcomes (8)

Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year.
Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from day 366 to death or study termination whichever occurs first, up to 3.6 years.
Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen
From start of treatment to end of treatment (approximately day 109).
Death During or Within 30 Days of Discontinuation of Protocol Treatment.
From start of treatment to 30 days after end of treatment (treatment ends approximately day 109).
One- and Two-year Distant Metastases-free Rates
From registration to two years
One- and Two-year Loco-regional Progression-free Rates
Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.
+3 more secondary outcomes

Study Arms (1)

Treatment (bevacizumab, cisplatin, fluorouracil, IMRT, 3D-CRT)

EXPERIMENTAL

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Radiation: 3-Dimensional Conformal Radiation TherapyBiological: BevacizumabDrug: CisplatinDrug: FluorouracilRadiation: Intensity-Modulated Radiation Therapy

Interventions

3-Dimensional Conformal Radiation TherapyRADIATION

Undergo 3D-CRT

Also known as: 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy