MedPath

CROSS II.

Completed
Conditions
Esophageal cancer.
Registration Number
NL-OMON20325
Lead Sponsor
/A
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
350
Inclusion Criteria

18 < age < 75 year, surgical resectable T2-3, N0-1, M0, tumour length longitudinal <8cm and radial <5cm, no invasion tracheobronchial tree, tumour must not extend more than 2 cm into the stomach, ECOG 0-2.

Exclusion Criteria

T1N1, T1N0, past or current history of malignancy other than entry diagnosis, previouw chemotherapy or radiotherapy, MI in last 6 months, congestive heart failure or arrhythmia requiring medication, neurotoxicity grade >1, inadequate caloric and or fluid intake, weight loss 10%.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. To compare median survival rates between patients treated for surgical resectable esophageal adenocarcinoma or squamous cell carcinoma;<br /><br>2. To compare quality of life before, during and after treatment.
Secondary Outcome Measures
NameTimeMethod
1. To compare pathological responses; <br /><br>2. Progression free survival; <br /><br>3. Number of R0 resections; <br /><br>4. Treatment toxicity; <br /><br>5. Costs.
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