Clinical trial · Interventional
Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
NCT02213497CI-TRIAL-00100429active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG (Fluorodeoxyglucose) PET | Radiation | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
- description
- Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
- interventionNames
- Radiation: 18F-FDG (Fluorodeoxyglucose) PET
- Drug: Carboplatin
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina * Patients with AJCC 7th edition clinical stage IIB-IIIC * Patient must be \>18 years of age. * Patients must have an ECOG Performance Status of 0-1 * Patients must be able to provide informed consent. * Patients must be surgical candidates with adequate hematologic, renal, hepatic and pulmonary function * serum AST and ALT \< 2 times the upper limit of normal * Patients must have bilirubin \< 1.5 × normal. * WBC \> 3000/mm3, platelets \> 100,000 mm3. * Hemoglobin \> 10 g/dL serum creatinine \< 1.5 times the upper limit of normal * Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented. Exclusion Criteria: * Patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should be measured by endoscopic findings, width should be measured by diagnostic CT or CT portion of PET/CT) * Patients with primary tumors located at or above the carina * Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) * Pregnant women, women planning to become pregnant and women that are nursing
References
Publications (0)
Data not yet available
No reference posted for this study.