Clinical trial · Interventional
Trimodality Management of T1b Esophageal Cancers
Phase IIB Study of Trimodality Management of Clinical T1bN0M0 Cancers of the Esophagus
NCT01217060CI-TRIAL-00051236completedPhase 1 / Phase 2Results postedClinicalTrials.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 clinical research study is to learn if giving chemotherapy and radiation therapy before surgery for early-stage esophageal cancer can help to control the disease and if so, for how long. The safety of this treatment will also be studied.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Esophagectomy | Procedure | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel + 5-FU + Radiation + Surgery
- description
- Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
- interventionNames
- Drug: Docetaxel
- Drug: 5-FU
- Radiation: Radiotherapy
- Procedure: Esophagectomy
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Pathologic Complete Response (PCR) Rate
- timeFrame
- Pathologic Complete Response (PCR) will repeat EGD with biopsy to assess for clinical response to therapy after chemoradiation four to six weeks.
- description
- The primary endpoint for this protocol is to assess the efficacy (pathologic complete response) and safety of Trimodality management (chemoradiotherapy followed by esophagectomy) in patients with clinically staged T1bN0M0 cancer of the esophagus or gastroesophageal junction. This is a single-arm phase IIB trial of chemo-radiation followed by surgery for patients with early stage grade T1b esophageal cancer. The rates of pathologic CR will be tabulated and their possible relationships to baseline covariates assessed by logistic regression. Unadjusted progression free survival time will be estimated by the method of Kaplan and Meier and its possible relationship to baseline covariates assessed by survival regression modeling.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically documented adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction that are staged as T1b using endoscopic ultrasound (EUS) or from a large biopsy (either criteria # 1 or #2 can be met for eligibility). 2. Patients who undergo a diagnostic Endoscopic Mucosal Resection (EMR) and have a diagnosis of T1b stage established. 3. Performance score Karnofsky Performance Scale (KPS) 80-100. 4. Patients should be surgical candidates for esophagectomy and should have no contraindications for chemotherapy or radiation. 5. Negative pregnancy test for women of child bearing potential. They must agree to adequate contraception. 6. Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, CO2, Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, ALT (SGPT), AST (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) \>2,500/uL, platelets \> 75,000/uL), renal (creatinine clearance \> 50 mL/min), and liver function (bilirubin \<=1.5 fold the upper limit of normal and liver enzymes \< 3 fold the upper limit of normal). 7. Based on the risk factors and propensity of lymph node metastasis (LNM) and poorer survivals seen in retrospective studies as discussed in the introduction, only patients with any one (1) of high risk features such as LVI, tumors \>1.2 cm, and high grade will be enrolled (Grade is the pathologic term defining the degree of differentiation. Grade 1 is well differentiated, Grade 2 is moderately differentiated, and Grade 3 is poorly differentiated). Exclusion Criteria: 1. Prior radiation to the chest 2. Previous or concomitant cancers other than 1) curatively treated carcinoma in situ of cervix, basal cell of the skin, curative treatment for transitional cell carcinoma of the bladder, and early stage cancers at another non-overlapping site that was treated more than 3 years ago for cure. 3. Pregnant or breast-feeding females 4. Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device c) no myocardial infarction within 3 months of registration 5. Known hypersensitivity to docetaxel, 5-fluorouracil, polysorbate-80, or any component of the formulation
References
Publications (0)
Data not yet available
No reference posted for this study.