--- title: Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer nct_id: NCT00072033 overall_status: COMPLETED phase: PHASE2 sponsor: Swiss Cancer Institute study_type: INTERVENTIONAL primary_condition: Esophageal Cancer countries: Switzerland canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00072033.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00072033" ct_last_update_post_date: 2012-06-05 last_seen_at: "2026-05-12T06:42:26.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer **Official Title:** Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial **NCT ID:** [NCT00072033](https://clinicaltrials.gov/study/NCT00072033) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 66 - **Lead Sponsor:** Swiss Cancer Institute - **Conditions:** Esophageal Cancer - **Start Date:** 2003-03 - **Completion Date:** 2010-05 - **CT.gov Last Update:** 2012-06-05 ## Brief Summary 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. ## Detailed Description OBJECTIVES: Primary * Determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy followed by surgery, in terms of pathological response rate, in patients with locally advanced, resectable esophageal cancer. * Determine the feasibility of this regimen, in terms of successful completion of therapy and survival at 30 days postoperatively, in these patients. Secondary * Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results. * Correlate early improvement of dysphasia after 1-2 courses of chemotherapy with predictive value with regard to tumor response and long-term disease control in patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. * Determine the clinical benefit of this regimen in these patients. OUTLINE: This is a multicenter study. * Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 22. * Chemoradiotherapy: Beginning 21 days after the last dose of neoadjuvant chemotherapy, patients receive docetaxel IV over 30 minutes and cisplatin IV over 1 hour once a week and undergo radiotherapy 5 days a week for 5 weeks. * Surgery: Patients undergo surgery 3-8 weeks after the final administration of radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 22 of chemotherapy, day 1 of chemoradiotherapy, before surgery, and then every 3 months for 1 year. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 22-66 patients will be accrued for this study. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 70 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 drugs ``` ## Arms - **Arm A** (ACTIVE_COMPARATOR) — Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery ## Interventions - **Cisplatin and Docetaxel** (DRUG) — cisplatin and docetaxel chemo- and radiochemotherapy ## Primary Outcomes - **Feasibility of successful study therapy completion and survival after surgery** _(time frame: 30 days)_ ## Secondary Outcomes - **Adverse events** _(time frame: 30 days)_ - **Overall survival** _(time frame: Life-long)_ - **Feasibility in Switzerland after surgery** _(time frame: 30 days)_ ## Locations (9) - Kantonspital Aarau, Aarau, Switzerland - Universitaetsspital-Basel, Basel, Switzerland - Inselspital Bern, Bern, Switzerland - Spitaeler Chur AG, Chur, Switzerland - Hopital Cantonal Universitaire de Geneve, Geneva, Switzerland - Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland - Ospedale Civico, Lugano, Switzerland - Kantonsspital - St. Gallen, Sankt Gallen, Switzerland - City Hospital Triemli, Zurich, Switzerland ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.kantonspital aarau|aarau||switzerland` — added _(2026-05-12)_ - `locations.universitaetsspital-basel|basel||switzerland` — added _(2026-05-12)_ - `locations.inselspital bern|bern||switzerland` — added _(2026-05-12)_ - `locations.spitaeler chur ag|chur||switzerland` — added _(2026-05-12)_ - `locations.hopital cantonal universitaire de geneve|geneva||switzerland` — added _(2026-05-12)_ - `locations.centre hospitalier universitaire vaudois|lausanne||switzerland` — added _(2026-05-12)_ - `locations.ospedale civico|lugano||switzerland` — added _(2026-05-12)_ - `locations.kantonsspital - st. gallen|sankt gallen||switzerland` — added _(2026-05-12)_ - `locations.city hospital triemli|zurich||switzerland` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00072033.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00072033* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*