A Randomized Trial of Dose Escalation in definitive Chemoradiotherapy for patients with Oesophageal cancer *ART DECO*

Patients with oesophageal cancer suffer a high chance of local recurrence
resulting in short term death. The local recurrence causes severe and frequent
complaints without possibilities for palliation. Radiation dose for oesophageal
cancer are traditionally low due to side effects as a result from large
irradiation fields used in the past. The dose is considerably lower than the
radiation dose applied for neighbouring tumors like hypopharyngeal cancer. The
treatmentresults are also poorer than with hypopharyngeal cancer. The addition
of chemotherapy as sensitizer for the radiation provved efficient as
demonstrated in the Dutch CROSS study comparing low dose radiation with and
without concomitant chemotherapy. As a successor of the forementioned study the
Dutch Oesophageal cancer group and the "landelijk platform Radiotherapie voor
Gastro-Enterologische tumoren" propose the undelying study. In this study we
use possibilities provided by modern radiation oncology to decreasing the dose
to the surrounding tissues. We use tis increase in therapeutic window to
increase the dose to the tumor whilst maintaining the dose to the organs at
risk to achieve a 15% increase in local control and avoidance of the complaints
en death a recurrence brings.

To improve the local tumor control rate by escalating the radiation dose in
definitive chemoradiotherapy for patients with locally irresectable or
medically inoperable carcinoma of the esophagus or gastric junction without
distant metastases (stage T1-4N0-3M0).

Multicenter, prospective randomized phase III clinical trial.
Arm I: standard dose of 50.4 Gy plus concurrent carboplatin and paclitaxel
Arm II: as arm I plus a concomitant daily boost dose of 0.4 Gy to the primary
tumor leading to a total tumordose of 61.6 Gy in 2.2 Gy fractions.

Radiation dose escalation to the primary tumor.

Arm I: standard dose of 50.4 Gy plus concurrent carboplatin and paclitaxel
Arm II: as arm I plus a concomitant daily concomitant boost dose of 0.4 Gy to
the primary tumor leading to a total tumordose of 61.6 Gy in 2.2 Gy fractions.

Patients in the experimental ar have a higher risk for radiation pneumonitis,
dysphagia caused by mucositis and ulceration. At long term there is a higher
risk for fibrotic stricutres and esophageal perforations.