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Perioperative Versus Preoperative Chemotherapy With Surgery in Patients With Locoregional Squamous Carcinoma of Esophagus

Phase 1
18 Years
Not Enrolling
Squamous Carcinoma of Esophagus, Esophagus Disorders

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Trial Information

Perioperative Versus Preoperative Chemotherapy With Surgery in Patients With Locoregional Squamous Carcinoma of Esophagus

Perioperative chemotherapy has been shown to significantly improve the R0 resection rate,
the disease free survival and the overall survival in patients with adenocarcinoma of the
esophagus, the gastroesophageal junction and the stomach. Therefore, perioperative
chemotherapy is the new therapeutic standard (Cunningham NEJM 2006, MRC, Lancet 2002, Boige
ASCO 2007). The best-evaluated regime is the combination of Epirubicin, Cisplatin and 5-FU
(ECF) (Cunningham, NEJM 2007). Cisplatin and 5-FU are considered to be the most important
components to form the cornerstone of this regime.

Paclitaxel is a new and highly active cytotoxic agent. In a randomized phase II study, the
dual combination of Paclitaxel and 5-FU seemed to show similar effects as ECF, administered
as first line treatment. The triplet combination of Paclitaxel, Cisplatin and 5-FU has
significantly superior efficacy than a combination of Cisplatin und 5-FU (Van Cutsem, JCO

It has been shown that Capecitabine is more active than 5-FU and can replace intravenous
5-FU in the combination with Cisplatin in the treatment of esophageal cancer. Capecitabine
therefore is FDA approved for esophageal cancer (Cunningham, ASCO 2006, Kang ASCO 2006).It
seems reasonable to optimize perioperative chemotherapy by including this modern

In this study, patients with squamous carcinoma of esophagus and gastroesophageal junction
who seem operable with curative intent according to oncological and surgical assessment are
treated with 2 preoperative cycles of PCF followed by surgical resection, followed by 2
postoperative cycles of PCF. Among patients with no responses to preoperative chemotherapy,
Capecitabine 625 mg/m² twice-daily dose is defined as alternatives to infused 5-Fluorouracil
in the postoperative chemotherapy regimen Postoperative chemotherapy will start within 4-6
weeks after the operation. 3 weeks after the end of the last chemotherapy the final
investigation (end of study visit) will be done.

Inclusion Criteria:

- Signed informed consent

- histologically confirmed esophageal cancer (squamous carcinoma) measurable,
non-metastatic disease

- no previous cancer therapy (chemotherapy, radiotherapy or resection)

- life expectancy > 3 months

- age > 18 years

- WHO Status ≤ 1

- Intended curative resection according to evaluation of an experienced surgeon

- Negative pregnancy blood test at screening but not earlier than 72 hours prior to
start of chemotherapy for women with child bearing potential

- Adequate haematologic function and liver and renal function: neutrophils > 1.5×109/L;
thrombocytes > 100×109/L; haemoglobin > 10 g/dl, creatinine clearance > 60 ml/min
(calculated according to Cockroft and Gault), total bilirubin < 1.0×UNL; AST and ALT
< 1.5×UNL, AP < 2.5×UNL

- Complete staging within 3 weeks prior to start of treatment (CT-scan of thorax and
abdomen, endosonography, gastroscopy)

- Ability to keep appointments and follow the study protocol

- By CT-scan, endoscopy or endosonography measurable or evaluable disease

Exclusion Criteria:

- Former therapy of cancer (operation, chemo- or radiotherapy)

- Diagnosis of another cancer in the last 5 years prior to study entry which has not
been cured by operation only (exception in-situ-carcinoma of the cervix or cured
non-melanomatose skin cancer)

- Known contraindication to the planned chemotherapeutics

- Presence of distant metastases

- Anamnestic known serious disease or other concomitant diseases that affect
participation in this study, such as:

oInstable cardiac disease: symptomatic heart failure, symptomatic coronary artery disease,
ventricular cardiac arrhythmia not well controlled with medication, myocardial infarction
or resuscitation within 6 month before study oActive infection necessitating systemic
therapy or uncontrolled infection oInterstitial lung diseases (for example: pneumonitis or
fibrosis of the lung) and indication for interstitial lung disease in chest x-ray or
CT-scan respectively oActive inflammatory bowel disease or other bowel diseases which
provoke chronic diarrhea (defined as > 4 bowel movements per day) oNeurological or
psychiatric disease including dementia, epilepsy or untreated, symptomatic brain
metastases oLimited hearing ability

- Presence of upper GI obstruction, leading to inability to swallow ground tablets

- Presence of acute or chronic systemic infection

- Presence of a bowel obstruction within the last 30 days

- Pregnant or lactating women or women with child bearing potential and men without
adequate contraception (high effective contraception, defined as Pearl Index < 1)
like birth control pill, hormone spiral, hormone implant, transdermal patch, a
combination of two barrier methods (condom and diaphragm), realized sterilization or
sexual abstinence during the study and at least for 3 months after the last infusion

- Any other situation which may lead to an unacceptable high risk for the patient, when
he participates in the study

- Parallel treatment in another clinical study or prior participation in this study

- Treatment with any other therapy against the tumor or any parallel radiation

- Symptomatic peripheral neuropathy NCI-CTCAE degree > 2

- Intolerance to the study medication

- Detention in a psychiatric unit or imprisonment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival rate

Outcome Time Frame:

5 years

Safety Issue:



China: Ethics Committee

Study ID:




Start Date:

January 1997

Completion Date:

January 2010

Related Keywords:

  • Squamous Carcinoma of Esophagus
  • Esophagus Disorders
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms