Advanced or Recurrent Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
A Randomized Phase II Trial of Capecitabine Plus Cisplatin (XP) Versus Capecitabine Plus Genexol (XG) as a First-line Treatment for Advanced or Recurrent Esophageal Squamous Cell Carcinoma
Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response
rates, which is most commonly used to treat patients with metastatic, recurrent or locally
advanced, unresectable squamous cell carcinoma of the esophagus. Because the classical dose
schedule of this two-drug combination is cisplatin 100 mg/m2 day 1 and 5-FU 1000 mg/m2/day
continuous infusion for 96-120 hr, prolonged administration time and mucosal toxicity are
inconvenient to the patients with the aim of palliation. Capecitabine, which is oral prodrug
of 5-FU and mimic continuously-infused 5-FU, is being investigated in phase I, II and III
trials for the treatment of gastric, gastroesophageal, and esophageal cancers, primarily in
the first-line metastatic setting but also in the adjuvant setting. In the investigators
experience, capecitabine plus cisplatin combination (XP) as a first-line treatment for 45
patients with advanced or recurrent esophageal squamous cell carcinoma demonstrated a
promising anti-tumor activity with 57% of response rate and showed tolerable toxicity with
convenience.
Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in
patients with advanced esophageal cancer. A Dutch phase II study demonstrated that
paclitaxel combination with carboplatin had shown an encouraging confirmed response rate of
59% with 51 patients with resectable esophageal cancer in neoadjuvant setting. Another Dutch
phase II study showed 43% of response rate including 4% of CR with 8 months of response
duration when paclitaxel plus cisplatin administration was given for patients with
metastatic esophageal cancer. Although recently first-line palliative chemotherapy regimen
in esophageal cancer has been investigated, many trials have failed to show superiority to
5-FU/cisplatin combination. Since the investigators considered that XP or XG (genexol) is
more effective and convenient chemotherapy regimen than 5-FU/cisplatin, this randomized
phase II study was planned to compare XP with XG in terms of efficacy and tolerability.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00816634 -
Efficacy Comparison Study of Combination Regimens to Treat Advanced Esophageal Squamous Cell Carcinoma
|
Phase 2 |