Clinical trial · Interventional
Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery
Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial
- 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 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel and Cisplatin | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
- interventionNames
- Drug: Docetaxel and Cisplatin
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Proportion of patients without local failure measured 6 months after completion of study treatment
- timeFrame
- 6 months
Secondary outcomes (3)
- measure
- Adverse reactions measured after completion of study treatment
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed esophageal cancer, including the gastroesophageal junction
* Squamous cell or adenocarcinoma
* Unresectable disease
* Meets 1 of the following staging criteria by endoscopic ultrasound:
* Cervical (supraclavicular) lesion, meeting 1 of the following stages:
* TX, N+ disease
* T3-4, NX disease
* TX, NX, M1a\* disease
* Thoracic (celiac) lesion, meeting 1 of the following stages:
* Unresectable T4, NX disease
* TX, NX, M1a\* disease
* Locally advanced resectable tumors, inoperable due to medical reasons NOTE: \*M1a requires unequivocal abnormality on staging CT scan/endosonography
* No T1-2, N0 disease
* All tumors encompassable in 1 radiation field
* No tumor with esophagotracheal fistula
PATIENT CHARACTERISTICS:
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* AST ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin normal
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine clearance \> 60 mL/min
Cardiovascular
* No myocardial infarction within the past 3 months
* No New York Heart Association class III or IV congestive heart failure
* No unstable angina pectoris
* No significant arrhythmias
* No other severe cardiovascular disease
Immunologic
* No uncontrolled active infection
* No active autoimmune disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after completion of study treatment
* No definite contraindication to corticosteroids
* No uncontrolled diabetes mellitus
* No pre-existing peripheral neuropathy \> grade 1
* No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent
* No other serious underlying medical condition that would preclude study participation
* No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior chemotherapy
Radiotherapy
* No prior radiotherapy to the chest
Other
* More than 30 days since prior experimental treatment in another clinical trial
* No other concurrent experimental drugsReferences
Publications (1)
- RESULTRuhstaller T, Templeton A, Ribi K, Schuller JC, Borner M, Thierstein S, von Moos R, Pederiva S, Lohri A, Lombriser N, von Briel C, Koeberle D, Popescu R. Intense therapy in patients with locally advanced esophageal cancer beyond hope for surgical cure: a prospective, multicenter phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 76/02). Onkologie. 2010;33(5):222-8. doi: 10.1159/000305094. Epub 2010 Apr 9. PMID 20502056