European Organisation for Research and Treatment of Cancer - EORTC
Status
Completed
Last Update Posted
Jan 20, 2012Estimated
Enrollment
27Estimated
Phase
Phase 1
Conditions
Colorectal Cancer
Head and Neck Cancer
Metastatic Cancer
Interventions
boronophenylalanine-fructose complex
sodium borocaptate
conventional surgery
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT00062348
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EORTC-11001
Secondary IDs
ID
Type
Description
Link
EORTC-11001
Brief Title
Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver Metastases
Official Title
B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA
Acronym
Not provided
Organization
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
Status Module
Record Verification Date
Jan 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2003
Primary Completion Date
Dec 2007Actual
Completion Date
Not provided
First Submitted Date
Jun 5, 2003
First Submission Date that Met QC Criteria
Jun 5, 2003
First Posted Date
Jun 6, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 19, 2012
Last Update Posted Date
Jan 20, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Diagnostic procedures using boronophenylalanine-fructose complex (BPA-F) and/or sodium borocaptate (BSH) to detect the presence of boron in tumor cells may help determine whether patients who have thyroid cancer, head and neck cancer, or liver metastases may benefit from boron neutron capture therapy.
PURPOSE: This phase I trial is studying the side effects of giving BPA-F and/or BSH before surgery to detect boron uptake in tissues of patients with primary, metastatic, or recurrent thyroid cancer, head and neck cancer, or liver metastases from colorectal cancer.
Detailed Description
OBJECTIVES:
Identify additional solid tumors that may benefit from boron neutron capture therapy.
Determine the boron concentration in the tumor, surrounding tissues, and blood of patients with operable thyroid cancer, squamous cell cancer of the head and neck, or liver metastases secondary to colorectal adenocarcinoma who receive boronophenylalanine-fructose complex (BPA-F) and/or sodium borocaptate (BSH) before surgical resection.
Determine the feasibility of using these drugs to obtain a favorable absolute boron-10 concentration in the tumor and optimal tumor-to-blood and tumor-to-healthy tissue boron-10 rates in these patients.
Determine the qualitative and quantitative toxicity of combined BPA-F and BSH administration in these patients.
OUTLINE: This is a multicenter study. Patients are sequentially assigned to 1 of 3 treatment groups.
Group I: Patients receive boronophenylalanine-fructose complex (BPA-F) IV over 1 hour. Two hours later, patients undergo surgical resection.
Group II: Patients receive sodium borocaptate (BSH) IV over 1 hour. Twelve hours later, patients undergo surgical resection.
Group III: Patients receive BSH IV over 1 hour (administered 12 hours prior to surgery) and BPA-F IV over 1 hour (administered 2 hours prior to surgery). Patients then undergo surgical resection.
During the planned surgery, tissue samples from the tumor and surrounding tissues are collected.
Patients are followed on days 1 and 5 and then at 4 weeks.
PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study.
Conditions Module
Conditions
Colorectal Cancer
Head and Neck Cancer
Metastatic Cancer
Keywords
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
27Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
boronophenylalanine-fructose complex
Drug
sodium borocaptate
Drug
conventional surgery
Procedure
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Boron uptake ratio in tumor vs normal tissue
Secondary Outcomes
Measure
Description
Time Frame
Toxicity measured by NCI-CTC v2.0 up to 28 days after injections
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor of 1 of the following malignant tumor types:
Squamous cell cancer of the head and neck
Thyroid cancer
Liver metastases* secondary to colorectal adenocarcinoma NOTE: *Liver metastases are eligible provided colorectal adenocarcinoma has been histopathologically proven and CT scan/MRI shows metastatic lesions in the liver
Operable disease for which a surgical excision is planned
Primary, metastatic, or locally recurrent disease
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
WHO 0-2
Life expectancy
Not specified
Hematopoietic
Neutrophil count at least 2,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL
Hepatic
Bilirubin no greater than 2.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2.5 times ULN
AST and ALT no greater than 2.5 times ULN
No other severe liver function impairment
Renal
Creatinine normal
BUN normal
Cardiovascular
No congestive heart failure
No angina pectoris
No recent coronary artery disease
No uncontrolled arrhythmias
No conduction defects
No other severe heart disease
Pulmonary
No severe obstructive or restrictive lung disease
Gastrointestinal
No severe gastrointestinal disease
No active peptic ulcer disease
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No pre-existing serious mental or organic brain disease (e.g., epilepsy)
No history of phenylketonuria (only in the case of BPA administration)
No severe allergic disease requiring continuous medication
No other concurrent severe disease
No uncontrolled endocrine disease
No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
More than 3 months since prior chemotherapy
Endocrine therapy
Not specified
Radiotherapy
No prior radiotherapy to the malignant site
Surgery
See Disease Characteristics
Other
Recovered from prior antitumor therapy (excluding alopecia)
Wittig A, Sheu-Grabellus SY, Collette L, Moss R, Brualla L, Sauerwein W. BPA uptake does not correlate with LAT1 and Ki67 expressions in tumor samples (results of EORTC trial 11001). Appl Radiat Isot. 2011 Dec;69(12):1807-12. doi: 10.1016/j.apradiso.2011.02.018. Epub 2011 Feb 16.
Bendel P, Wittig A, Basilico F, Mauri PL, Sauerwein W. Metabolism of borono-phenylalanine-fructose complex (BPA-fr) and borocaptate sodium (BSH) in cancer patients--results from EORTC trial 11001. J Pharm Biomed Anal. 2010 Jan 5;51(1):284-7. doi: 10.1016/j.jpba.2009.08.018. Epub 2009 Aug 22.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
untreated metastatic squamous neck cancer with occult primary
recurrent thyroid cancer
stage IV follicular thyroid cancer
stage IV papillary thyroid cancer
stage IVA colon cancer
stage IVB colon cancer
recurrent colon cancer
adenocarcinoma of the colon
recurrent rectal cancer
stage IVA rectal cancer
stage IVB rectal cancer
adenocarcinoma of the rectum
anaplastic thyroid cancer
insular thyroid cancer
thyroid gland medullary carcinoma
liver metastases
stage I squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the nasopharynx
stage I squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I papillary thyroid cancer
stage II papillary thyroid cancer
stage III papillary thyroid cancer
stage I follicular thyroid cancer
stage II follicular thyroid cancer
stage III follicular thyroid cancer
recurrent metastatic squamous neck cancer with occult primary
Wittig A, Collette L, Appelman K, Buhrmann S, Jackel MC, Jockel KH, Schmid KW, Ortmann U, Moss R, Sauerwein WAG. EORTC trial 11001: distribution of two 10B-compounds in patients with squamous cell carcinoma of head and neck, a translational research/phase 1 trial. J Cell Mol Med. 2009 Aug;13(8B):1653-1665. doi: 10.1111/j.1582-4934.2009.00856.x. Epub 2009 Jul 10.
Wittig A, Malago M, Collette L, Huiskamp R, Buhrmann S, Nievaart V, Kaiser GM, Jockel KH, Schmid KW, Ortmann U, Sauerwein WA. Uptake of two 10B-compounds in liver metastases of colorectal adenocarcinoma for extracorporeal irradiation with boron neutron capture therapy (EORTC Trial 11001). Int J Cancer. 2008 Mar 1;122(5):1164-71. doi: 10.1002/ijc.23224.