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Completed

NCT Number: NCT00213486

Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial

The standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.

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Key information

Conditions

Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Rouen

Rouen, 76031, France

About this study

Chemotherapy with weekly cisplatin 30 mg/m2 AND Irinotecan 60 mg/m2 was administered at days1,8,22,29 and concurrently with radiotherapy t days 43,50,64,71. Radiotherapy was delivered day 43 to 75 with 50Gy in 25 fractions/5 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed
  • performance status <OR=2 (ECOG)
  • caloric intake>1500 KCal/d
  • serum albumin >32 gr/l
  • serum creatinine<120 microgr/l
  • total serum bilirubin < 1.5 mg/ml
  • no prior chemotherapy or radiotherapy or surgery for esophageal neoplasm
  • no prior history of malignancy other than cell carcinoma of the skin, in siyu cervical carcinoma, or head and neck carcinoma with complete response since 3 years
  • written informed consent

Exclusion criteria

  • Gilbert's syndrome
  • cardiac disease as NYHA class 3 or 4
  • myocardial infarction within the previous 6 months
  • metastatic disease
  • histologically proved invasion of tracheobronchial tree
  • metastatic disease

Treatment and study plan

Irinotecan

Drug

Primary outcomes

  1. clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan

Secondary outcomes

  1. toxicity profile

  2. overall survival rate at one and two years

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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