Clinical trial · Interventional
Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Esophageal Cancer
Phase I Trial With Weekly Docetaxel, Capecitabine and Carboplatin as Induction Chemotherapy Followed by Concomitant Capecitabine and Radiotherapy in Patients With Locally Advanced Esophageal Cancer
- 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)
RATIONALE: Drugs used in chemotherapy, such as docetaxel, carboplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with carboplatin and capecitabine followed by chemoradiotherapy in treating patients who are undergoing surgery for locally advanced 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 |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed esophageal or gastroesophageal junction cancer
* Locally advanced disease, meeting 1 of the following staging criteria:
* T3, N0, M0 disease
* Any T, N1, M0 disease
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
Hepatic
* Bilirubin normal
* Meets 1 of the following criteria:
* Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST/ALT normal
Renal
* Creatinine ≤ 2.0 mg/dL
* Creatinine clearance ≥ 80 mL/min
Cardiovascular
* No uncontrolled congestive heart failure
* No symptomatic coronary artery disease
* No uncontrolled arrhythmias
* No myocardial infarction within the past 12 months
* No other uncontrolled clinically significant cardiac disease
Gastrointestinal
* Able to swallow tablets
* Intact upper gastrointestinal tract
* No malabsorption syndrome
Immunologic
* No history of unanticipated severe reaction to fluoropyrimidine
* No known hypersensitivity to fluorouracil
* No severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No serious infection that requires continuous antibiotic therapy
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
* No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No history of seizures
* No history of serious psychiatric illness that would preclude study compliance or giving informed consent
* No peripheral neuropathy \> grade 1
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior chemotherapy
Radiotherapy
* No prior radiotherapy
Other
* More than 28 days since prior investigational drugs
* No concurrent warfarin for active anticoagulationReferences
Publications (1)
- RESULTRao S, Oelschlager BK, Koh WJ, et al.: Phase I trial with weekly docetaxel, capecitabine and carboplatin followed by concomitant capecitabine and radiotherapy in patients with locally advanced esophageal cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-123, 2008.