Clinical trial · Interventional
EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer
Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
NCT00896961CI-TRIAL-00008941terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage II Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage III Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| EF5 | Drug | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Observational (EF5)
- description
- Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration.
- interventionNames
- Drug: EF5
- Other: diagnostic laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (3)
- measure
- Time to locoregional recurrence in HNSCC patients
- timeFrame
- Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years
- measure
- Time to distant metastasis in STS patients
- timeFrame
- Time from study entry (EF5 administration) to distant metastasis, assessed up to 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed high-grade soft tissue sarcoma (STS) of the trunk or extremity or squamous cell carcinoma of the oral cavity for which surgical biopsy or resection is standard initial therapy * Clinical imaging of mass that is likely to be STS or squamous cell carcinoma of the head and neck allowed if surgery is indicated prior to definitive diagnosis * Planned resection and standard oncologic treatment * No known distant metastatic disease * ECOG 0-2 * WBC at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin less than 2.0 mg/dL * Creatinine less than 2.0 mg/dL OR creatinine clearance at least 50 mL/min * No significant cardiac condition that would preclude study compliance * Weight no greater than 130 kg * No grade III or IV peripheral neuropathy * No other medical condition that would preclude study compliance * Not pregnant or nursing * Fertile patients must use effective contraception * See Disease Characteristics * No chemotherapy within 3 months before planned surgery * Preoperative radiotherapy allowed for STS * No radiotherapy within 3 months before planned surgery * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.