Clinical trial · Interventional
Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus
NCT00069953CI-TRIAL-00026019completedPhase 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)
RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, 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. Combining chemotherapy with radiation therapy may kill more tumor cells PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ChemoRT and selective surgery
- description
- Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
- interventionNames
- Biological: filgrastim
- Biological: pegfilgrastim
- Drug: cisplatin
- Drug: fluorouracil
- Drug: paclitaxel
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival (1-year Rate Reported)
- timeFrame
- From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.
- description
- One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction * Primary (non-recurrent) disease * Amenable to resection * Stage greater than T1, N0 by endoscopic ultrasound * Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue * Tumor may not extend more than 2 cm into the stomach * No multiple primary carcinomas of the esophagus * No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus * No evidence of disseminated cancer * Suggestion of liver metastases by positron emission tomography must be proven negative by biopsy or other imaging studies * Palpable supraclavicular nodes must be negative for cancer by biopsy * Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion * No celiac adenopathy greater than 2 cm PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 150,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Not specified Renal * Creatinine no greater than 1.5 mg/dL AND/OR * Creatinine clearance at least 65 mL/min * Calcium no greater than 11 mg/dL Cardiovascular * No uncontrolled heart disease * No uncontrolled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to comprehend study requirements and considered likely to comply with study parameters * No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix * No uncontrolled diabetes * No hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 5 years since prior systemic chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior chest or upper abdomen radiotherapy Surgery * No prior esophageal or gastric surgery Other * No concurrent photodynamic therapy * No other concurrent investigational agents for esophageal carcinoma
References
Publications (1)
- RESULTSwisher SG, Winter KA, Komaki RU, Ajani JA, Wu TT, Hofstetter WL, Konski AA, Willett CG. A Phase II study of a paclitaxel-based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1967-72. doi: 10.1016/j.ijrobp.2011.01.043. Epub 2011 Apr 18. PMID 21507583