simultaneous-integrated boost to the centre of a tumor in radiotherapy of big tumors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015763

Enrollment

Registered

2018-11-09

Start date

2019-01-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

locally advcanced or metastastic oncologic diseases of all types

Interventions

Group 1: Radiotherapy to the tumor with 10 x 3 Gy, simultenous-integrated boost to the centre of the tumor with 10 x 6 Gy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients with indication for palliative radiotherapy in malignant Tumors of all types. diameter of the tumor or a single metastasis is at least 4 cm. possibility of contouring a tumor-core with at least 2 cm diameter and a margin of 1 cm in all directions inside the Tumor. age =18 years. consent to participation.

Exclusion criteria

Exclusion criteria: critical healthy tissue inside the tumor-vloume (GTV). indication for surgical treatment or any other primary definitive treament Option. legal incapacity or missing consent. pregnancy and breastfeeding. renal dysfunction stage 4 or 5 (GFR < 30ml/min)

Design outcomes

Primary

Measure	Time frame
Name of the Outcome: feasibility Metric/Measurement: paper-based, comparison of planned and delivered fractions for each Patient, in at least 80% of all patients the counters are equal. Timepoint: 6 weeks after Treatment of the 25th patient	—

Secondary

Measure	Time frame
1. Name of the Outcome: Sideeffects Metric/Measurement: paper-based, continous Evaluation of all typical CTCAE criteria for acute toxicities, in less than 20% of the patients toxicities are = Grad 2 Timepoint: 6 weeks after Treatment of the 25th patient 2. Name of the Outcome: Quality of Life Metric/Measurement: paper-based, EORTC QLQ-C15-PAL questionaire, improvement of the score from the time before Treatment to 6 weeks after Treatment, describing Evaluation Timepoint: 6 weeks after Treatment of the 25th patient	—

Measure

Time frame

1. Name of the Outcome: Sideeffects Metric/Measurement: paper-based, continous Evaluation of all typical CTCAE criteria for acute toxicities, in less than 20% of the patients toxicities are = Grad 2 Timepoint: 6 weeks after Treatment of the 25th patient 2. Name of the Outcome: Quality of Life Metric/Measurement: paper-based, EORTC QLQ-C15-PAL questionaire, improvement of the score from the time before Treatment to 6 weeks after Treatment, describing Evaluation Timepoint: 6 weeks after Treatment of the 25th patient

—

Countries

Germany

Contacts

Public ContactOlaf Wittenstein

UKSH Klinik für Strahlentherapie Kiel

olaf.wittenstein@uksh.de+49 431 500 26501

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026