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Dose escalation study for inoperable esophageal cancer patients.

A randomised trial of dose escalation in definitive chemoradiotherapy for patients with oesophageal cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25587
Enrollment
260
Registered
2012-07-10
Start date
2012-08-15
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

inoperable oesophageal tumors definitive chemoradiation dose escalation

Interventions

An increase of the radiation dose of on the primary tumor, from the standard dose of 50,4 Gy in daily fractions of 1.8 Gy, to 61.6 Gy in fractions of 2.2 Gy. The dose escalation will be administered w

Sponsors

dept of Radiotherapy, AMC, Amsterdam Arhems Radiotherapeutisch Institute, Arnhem dept of oncology, Erasmusmc, Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. T1-4, N0-3,M0 medically or technically inoperable esophageal or junction tumors; 2. Histology proven; 3. WHO 0-2; 4. Tumor 18; 6. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Esophageal fistula; 2. Both pathological nodes at supraclavicular and truncus coeliacus level; 3. Junction tumors with supraclavicular nodes histology other than squamous-, adeno- or large cell carcinoma; 4. Extensive CIS of the esophagus outside the planned RT field; 5. Esophageal stent; 6. Secondary malignancies other than bcc of the skin and DCIS of breast/cervix uteri; 7. Severe heart of neurologic disease.

Design outcomes

Primary

MeasureTime frame
Local tumor control in the esophagus. Measured by anamnesis at 1, 2, 5, 8, 12, 18, 24, 36, 48 and 60 months, and by CT scans at 2, 8 and 18 months. Endoscopy and PET CT scan will be performed on indication.

Secondary

MeasureTime frame
Survival and grade 3-4 toxicity, measured at the same interval as local tumor control using an oesofagus toxicity form.

Contacts

Public ContactM.C.C.M. Hulshof

Dept of Radiotherapy Meibergdreef 9

m.c.hulshof@amc.nl+31 (0)20 5664231

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)