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Chemoradiation for irresectable (T4) esophageal cancer, a phase II multicenter study.

Chemoradiation for irresectable (T4) esophageal cancer, a phase II multicenter study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20123
Enrollment
43
Registered
2005-09-19
Start date
2003-10-30
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Esophageal cancer

Interventions

Paclitaxel 50mg/m2 and carboplatin AUC=2 on days 1, 8, 15, 22, 29 and 36. A total of 50.4 Gy will be given in 28 fractions of 1.8Gy, 5 fractions per week, starting on the first day of chemotherapy.

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. T4N0-1M0; 2. tumour length <10 cm; 3. upper tumour border 2 cm of upper esophageal sphincter; 4. tumor mus not extend more than 4 cm into the stomach; 5. WHO 0-2; 6. adequate haematological, renal, hepatic and pulmonal function, adequate caloric- and/or fluid intake.

Exclusion criteria

Exclusion criteria: 1. Previous chemotherapy and or radiotherapy on mediastinum or upper abdomen; 2. MI within last 6 months; 3. ventricular arrhythmia or congestive heart failure; 4. second or third degree heart blocks; 5. pre-existing neurotoxicity grade >1; 6. active infection.

Design outcomes

Primary

MeasureTime frame
To determine clinically complete biopsy proved response rate after a chemotherapy regime for patients with locally irresectable carcinoma of the esophagus or gatric junction without distant metastases (stage T4N0-1MO). To evaluate toxicity of this chemotherapy regimen in this group of patients.

Secondary

MeasureTime frame
To determine time to progression (TTP) of the disease after treatment. To determine quality of life before, during and after treatment. To obtain insight in survival after treatment.

Contacts

Public ContactA. Gaast, van der

Erasmus Medical Center, Department of Medical Oncology, P.O. Box 2040,

a.vandergaast@erasmusmc.nl+31 (0)10 4634897

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)