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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00213486

Enrollment

Registered

2005-09-21

Start date

2003-01-15

Completion date

2006-06-23

Last updated

2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms

Brief summary

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.

Detailed description

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.

Interventions

DRUGirinotecan

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan	—

Secondary

Measure	Time frame
toxicity profile	—
overall survival rate at one and two years	—

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPierre MICHEL, MD

Federation Francophone de Cancerologie Digestive

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026