Clinical trial · Interventional
PET/CT-directed Hyperfractionated Radiation Dose Escalation in Esophageal Cancer
Phase I Study of PET/CT-directed Hyperfractionated Radiation Dose Escalation With Concurrent Weekly Carboplatin and Paclitaxel in Esophageal Cancer
NCT03113214CI-TRIAL-00037974completedN/AClinicalTrials.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)
The goal of this study is to find the maximum tolerable dose of radiation that can be delivered with concurrent chemotherapy (carboplatin \& paclitaxel) in patients with esophageal cancer.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiochemotherapy 1 | Radiation | — | UNRESOLVED |
| radiochemotherapy 2 | Radiation | — | UNRESOLVED |
| radiochemotherapy 3 | Radiation | — | UNRESOLVED |
| radiochemotherapy 4 | Radiation | — | UNRESOLVED |
| radiochemotherapy 5 | Radiation | — | UNRESOLVED |
| radiochemotherapy 6 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- radiochemotherapy 1
- description
- Patients will be treated with radiation therapy 57.2 Gy.
- interventionNames
- Radiation: radiochemotherapy 1
- type
- EXPERIMENTAL
- label
- radiochemotherapy 2
- description
- Patients will be treated with radiation therapy 64.4 Gy.
- interventionNames
- Radiation: radiochemotherapy 2
- type
- EXPERIMENTAL
- label
- radiochemotherapy 3
- description
- Patients will be treated with radiation therapy 71.6 Gy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed primary squamous cell carcinoma of the esophagus 2. Age 1 8-75. 3. Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons. 4. Patients with distant metastasis and life expectancy \>/= 3 months are eligible. 5. Zubrod performance status 0 to 2 6. No prior radiation to the thorax that would overlap with the current treatment field. 7. Patients with nodal involvement are eligible 8. Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</=1 .5 times ULN. 9. A signed informed consent must be obtained prior to therapy. 1 0. Induction chemotherapy is allowed Exclusion Criteria: 1. The presence of a fistula. 2. Prior radiotherapy that would overlap the radiation fields. 3. gastroesophageal junction cancer. 4. Uncontrolled concurrent illness including, but not limited to: Chronic 5.Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. 6.Known hypersensitivity to paclitaxel. 7.Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. Acquired Immune Deficiency Syndrome. 8.Conditions precluding medical follow-up and protocol compliance
References
Publications (0)
Data not yet available
No reference posted for this study.