Clinical trial · Interventional
Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
Phase I Study of Dose Escalation Using Image-guided Radiotherapy to Deliver a Stereotactic Radiosurgical Boost After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Esophageal Cancer
NCT00368329CI-TRIAL-00007437terminatedPhase 1ClinicalTrials.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): low accrual
Summary
Brief summary (as posted)
To study the safety and feasibility of stereotactic radiation dose escalation following neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating the acute and late toxicity of treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18-F] Fluorodeoxyglucose (FDG) | Drug | — | UNRESOLVED |
| 5-Fluorouracil (5-FU) | Drug | Fluorouracil | ALIAS |
| Capecitabine (Xeloda) | Drug | Capecitabine | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion.
- measure
- The inked margins on the definitive surgical specimen will be inked and margin status, size of the tumor, evidence of residual tumor will be recorded.
- measure
- Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation.
- timeFrame
- after completion of their neoadjuvant chemoradiation
Secondary outcomes (4)
- measure
- Physical exam
- timeFrame
- Once every three months for two years, then every six months for three years and then once a year.
- measure
- CT scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:- Confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus by pathologist. * Endoscopic ultrasound or CT evidence of tumor penetration through the esophageal wall or involvement of regional lymph nodes, without evidence of distant metastasis * No prior chest radiation therapy * No prior chemotherapy for esophageal cancer * Age greater than 18 years * No infections requiring antibiotic treatment * Able to care for self * Patients must have acceptable liver, kidney and bone marrow function. * The effects of the chemotherapy drugs on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception. Exclusion Criteria:- Patients receiving any other investigational agents * Evidence of distant metastases * Uncontrolled medical illness * Any malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. * Pregnant and breastfeeding women are excluded. * HIV-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.