Clinical trial · Interventional
High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer
Phase II Trial of High Dose PET/CT-guided Radiation Therapy With Concurrent Weekly Carboplatin and Paclitaxel in Localregionally Advanced Esophageal Cancer
NCT03936179CI-TRIAL-00050767unknownN/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)
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high dose radiation therapy with concurrent chemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- high dose radiochemotherapy
- description
- A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy
- interventionNames
- Radiation: high dose radiation therapy with concurrent chemotherapy
Primary outcomes (1)
- measure
- overall survival rate
- timeFrame
- one year
- description
- survival time was measured from the date of study enrollment to the date of death or last follow-up
Secondary outcomes (1)
- measure
- acute and late toxicities
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have FDG-avid and histologically or cytologically proven esophageal cancer. * Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 No prior radiation to the thorax that would overlap with the current treatment field. * Patients with nodal involvement are eligible * 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. * A signed informed consent must be obtained prior to therapy. * No prior radiation to the thorax that would overlap with the current treatment field. Induction chemotherapy is allowed. Exclusion Criteria: * The presence of a fistula. * Prior radiotherapy that would overlap the radiation fields. * gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall. * Uncontrolled concurrent illness including, but not limited to: Chronic 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. * Known hypersensitivity to paclitaxel. * 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. * Conditions precluding medical follow-up and protocol compliance
References
Publications (0)
Data not yet available
No reference posted for this study.