Clinical trial · Interventional
Radiation Therapy and Paclitaxel, Carboplatin, and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer
NCT00022139CI-TRIAL-00025038completedPhase 2ClinicalTrials.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: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy and giving them before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy followed by esophagectomy works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction.
Conditions
Conditions (2)
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 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- carboplatin + paclitaxel + fluorouracil + radiation + surgery
- description
- Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and fluorouracil IV continuously on days 1-42. Beginning on day 1 of chemotherapy, patients undergo radiotherapy to the esophagus 5 days a week for 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete dissection of the mediastinal and perigastric lymph nodes. Beginning 8 weeks after surgery, patients who underwent curative resection may receive a maximum of 2 additional courses of paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before chemotherapy on days 1 and 22, and within 2 weeks before surgery. Patients are followed every 3 months for 4 years.
- interventionNames
- Drug: carboplatin
- Drug: fluorouracil
- Drug: paclitaxel
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Proportion of successes
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction * Surgically resectable disease (T1-3; NX, N0, or N1; M1a) * T4 tumors that are not unequivocally unresectable allowed * Celiac lymph node (stations 15-20) involvement allowed * Must be considered a potential surgical candidate by a thoracic or general surgeon * No supraclavicular lymph node involvement by palpation, biopsy, or radiograph (greater than 1.5 cm) * No distant metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 * Patients with ECOG 2 must be considered good candidates for study by treating oncologists Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease Other * No uncontrolled infection * No other severe underlying disease that would preclude study participation * No grade 2 or greater peripheral neuropathy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for esophageal cancer Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to anticipated fields of study radiotherapy Surgery * Not specified Other * No concurrent diuretics * No concurrent amifostine
References
Publications (3)
- BACKGROUNDJatoi A. Aggressive multimodality therapy for patients with locally advanced esophageal cancer: is there a role for amifostine? Semin Oncol. 2003 Dec;30(6 Suppl 18):72-5. doi: 10.1053/j.seminoncol.2003.11.013. PMID 14727244
- RESULTJatoi A, Martenson JA, Foster NR, McLeod HL, Lair BS, Nichols F, Tschetter LK, Moore DF Jr, Fitch TR, Alberts SR; North Central Cancer Treatment Group (N0044). Paclitaxel, carboplatin, 5-fluorouracil, and radiation for locally advanced esophageal cancer: phase II results of preliminary pharmacologic and molecular efforts to mitigate toxicity and predict outcomes: North Central Cancer Treatment Group (N0044). Am J Clin Oncol. 2007 Oct;30(5):507-13. doi: 10.1097/COC.0b013e31805c139a. PMID 17921712
- RESULTJatoi A, Martenson J, Mahoney MR, Lair BS, Brindle JS, Nichols F, Caron N, Rowland K, Tschetter L, Alberts S. Results of a planned interim toxicity analysis with trimodality therapy, including carboplatin AUC = 4, paclitaxel, 5-fluorouracil, amifostine, and radiation for locally advanced esophageal cancer: preliminary analyses and treatment recommendations from the North Central Cancer Treatment Group. Int Semin Surg Oncol. 2004 Nov 8;1(1):9. doi: 10.1186/1477-7800-1-9. PMID 15533252