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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Esophageal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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irinotecan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Pierre MICHEL, MD

Role: PRINCIPAL_INVESTIGATOR

Federation Francophone de Cancerologie Digestive

Locations

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CHU de Rouen

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2001/141/HP

Identifier Type: -

Identifier Source: org_study_id