Clinical trial · Interventional
Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With 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, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced, resectable 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 |
|---|---|---|---|
| Cisplatin and Docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery
- interventionNames
- Drug: Cisplatin and Docetaxel
Primary outcomes (1)
- measure
- Feasibility of successful study therapy completion and survival after surgery
- timeFrame
- 30 days
Secondary outcomes (3)
- measure
- Adverse events
- timeFrame
- 30 days
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
* Locally advanced disease that is technically operable with curative intent (R0)
* T3, N0 OR T1-3, N+ OR T4, NX
* No T1-2, N0
* No inoperable T4 (unequivocal organ involvement)
* No distant metastasis, including M1a lymph node status
* Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
* No carcinoma of the cervical esophagus
* Obstructive tumors allowed
PATIENT CHARACTERISTICS:
Age
* 18 to 70
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* AST no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
* Bilirubin no greater than 1.5 times ULN
Renal
* Creatinine clearance greater than 60 mL/min
Cardiovascular
* No New York Heart Association class III or IV congestive heart failure
* No unstable angina pectoris
* No myocardial infarction within the past 3 months
* No significant arrhythmias
* No other severe or uncontrolled cardiovascular disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after study treatment
* No definite contraindications to corticosteroids as premedication
* No geographic situation that would preclude proper staging and follow-up
* No active uncontrolled infection
* No preexisting peripheral neuropathy greater than grade 1
* No uncontrolled diabetes mellitus
* No active autoimmune disease
* No other serious 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
* No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures that would preclude comprehension and ability to provide informed consent and complete quality of life questionnaires
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the chest
Surgery
* Not specified
Other
* More than 30 days since prior treatment on another clinical trial
* No other concurrent experimental drugsReferences
Publications (7)
- RESULTJost C, Binek J, Schuller JC, Bauerfeind P, Metzger U, Werth B, Knuchel J, Frossard JL, Bertschinger P, Brauchli P, Meyenberger C, Ruhstaller T. Endosonographic radial tumor thickness after neoadjuvant chemoradiation therapy to predict response and survival in patients with locally advanced esophageal cancer: a prospective multicenter phase ll study by the Swiss Group for Clinical Cancer Research (SAKK 75/02). Gastrointest Endosc. 2010 Jun;71(7):1114-21. doi: 10.1016/j.gie.2009.12.015. Epub 2010 Mar 20. PMID 20304399
- RESULTKlaeser B, Nitzsche E, Schuller JC, Koberle D, Widmer L, Balmer-Majno S, Hany T, Cescato-Wenger C, Brauchli P, Zund M, Pestalozzi BC, Caspar C, Albrecht S, von Moos R, Ruhstaller T. Limited predictive value of FDG-PET for response assessment in the preoperative treatment of esophageal cancer: results of a prospective multi-center trial (SAKK 75/02). Onkologie. 2009 Dec;32(12):724-30. doi: 10.1159/000251842. Epub 2009 Nov 9. PMID 20016233
- RESULTRuhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, BalmerMajno S, Koberle D, Terraciano L, Schnider A, Bodis S, Popescu R; Swiss Group for Clinical Cancer Research (SAKK). Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol. 2009 Sep;20(9):1522-1528. doi: 10.1093/annonc/mdp045. Epub 2009 May 22. PMID 19465425
- RESULTSchuller JC, Balmer-Majno S, Mingrone W, et al.: Preoperative induction chemotherapy with docetaxel-cisplatin followed by concurrent docetaxel-cisplatin and radiation therapy (RT) in patients with locally advanced esophageal cancer: final results of the multicenter phase ll trial SAKK 75/02. [Abstract] J Clin Oncol 26 (Suppl 15): A-4550, 2008.
- RESULTRibi K, Nitzsche E, Schuller J, et al.: PET scanning and patient reported dysphagia before and after chemotherapy (CT) for prediction of pathological response after CT and chemoradiotherapy (CRT) in patients with locally advanced esophageal cancer (EC): a multicenter phase ll trial of the Swiss. [Abstract] J Clin Oncol 25 (Suppl 18): A-4587, 2007.