Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer
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| Study Type: | Interventional |
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| Study Design: | Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Stage II Squamous Cell Carcinoma of the Nasopharynx Stage III Lymphoepithelioma of the Nasopharynx Stage III Squamous Cell Carcinoma of the Nasopharynx Stage IV Lymphoepithelioma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Nasopharynx |
| Interventions: |
Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy Biological: bevacizumab Drug: cisplatin Drug: fluorouracil |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) |
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, 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. |
Participant Flow: Overall Study
| Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) | |
|---|---|
| STARTED | 46 |
| COMPLETED | 44 [1] |
| NOT COMPLETED | 2 |
| Ineligible | 1 |
| No protocol treatment | 1 |
| [1] | Subjects contributing data to the primary analysis are considered to have completed the study. |
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Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) |
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, 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. |
Baseline Measures
| Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) | |
|---|---|
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Number of Participants
[units: participants] |
46 |
|
Age
[units: years] Median ( Full Range ) |
48
( 18 to 63 ) |
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Gender
[units: participants] |
|
| Female | 16 |
| Male | 30 |
Outcome Measures
| 1. Primary: | Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year. [ Time Frame: From start of treatment to one year. ] |
| 2. Secondary: | Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year. [ Time Frame: From day 366 to end of follow-up. ] |
| 3. Secondary: | Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen [ Time Frame: 109 From start of treatment to end of treatment (approximately day 109). ] |
| 4. Secondary: | Death During or Within 30 Days of Discontinuation of Protocol Treatment. [ Time Frame: From discontinuation of protocol treatment to 30 days after. ] |
| 5. Secondary: | One- and Two-year Distant Metastases-free Rates [ Time Frame: From registration to two years. ] |
| 6. Secondary: | One- and Two-year Loco-regional Progression-free Rates [ Time Frame: From registration to two years. ] |
| 7. Secondary: | One- and Two-year Progression-free Survival Rates [ Time Frame: From registration to two years. ] |
| 8. Secondary: | One- and Two-year Overall Survival Rates [ Time Frame: From registration to two years. ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
Results Point of Contact:
Organization: Radiation Therapy Oncology Group (RTOG)
e-mail: wseiferheld@acr.org
No publications provided by National Cancer Institute (NCI)
Publications automatically indexed to this study:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00408694 History of Changes |
| Obsolete Identifiers: | NCT00707096 |
| Other Study ID Numbers: | NCI-2009-00736, RTOG-0615, U10CA021661, CDR0000518526 |
| Study First Received: | December 6, 2006 |
| Results First Received: | March 1, 2013 |
| Last Updated: | March 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |