A registry study to collect data on tumor shrinkage resulting from radiation therapy
- Gender
- Women and men
- Age
- 18 years and older
- Trial type
- Observational
- Line of therapy
- all
- Phase
- —
What is this trial about?
Radiation therapy is a component of the treatment for large-volume tumors, and various irradiation techniques can be used. To date, however, knowledge about these treatments has been based primarily on retrospective analyses. Therefore, long-term data collected prospectively as part of a study are needed. The goal of the SHRINK study is to systematically collect treatment data on various forms of radiation therapy and to compare conventional radiation therapy with spatially fractionated radiation therapy. Women and men aged 18 and older with a large-volume tumor exceeding 150 ml and an indication for radiation therapy are eligible to participate in this study.
Trial flow
Requirements
Diagnosis: tumors
Age: 18 years and older
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: large tumor volume (above 150 ml); indication for radiotherapy
Allocation
Einarmige Studie
Treatment
Follow-up
Diagnosis: tumors
Age: 18 years and older
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: large tumor volume (above 150 ml); indication for radiotherapy
Einarmige Studie
Detailed description
The treatment of large-volume tumors is complex and depends on numerous factors. One component of treatment may be radiation therapy, in which high-energy radiation is used to damage the tumor cells. The primary goal of treatment is to reduce the tumor’s size, which is intended to alleviate symptoms or improve the tumor’s resectability. Various radiation techniques are available within the framework of radiation therapy, including conventional and volumetric modulated arc therapy (VMAT). In conventional radiation therapy, the entire tumor is treated with the same radiation dose. In the case of large tumors, this can result in damage to a relatively large amount of surrounding healthy tissue. At the same time, the effectiveness in certain areas of the tumor may be limited due to the total radiation dose that must be adhered to. For this reason, spatially fractionated radiation therapy is increasingly being used for larger tumors. In this approach, specific sections of the tumor are treated with very high radiation doses, whereas other parts of the tumor receive only a small amount of radiation. The targeted destruction of cancer cells is thought to release various signaling molecules that can also damage surrounding cancer cells that have received lower doses of radiation (the so-called bystander effect). This method is intended to better spare the surrounding healthy tissue.
The aim of this registry study is the structured collection of long-term treatment data on various forms of radiation therapy for large-volume tumors. In particular, the study aims to compare tumor response and the occurrence of side effects between conventional and spatially fractionated radiation therapy. The treatment technique recommended by the treating physicians will be used as part of the study. No new therapeutic approach is being investigated. Clinical and imaging examinations will be performed before the start of therapy, on the last day of treatment, and at subsequent follow-up visits. As part of regular follow-up care, check-ups are scheduled approximately four to six weeks after the end of therapy and subsequently every three to six months. The study is being conducted as a single-center trial at Heidelberg University Hospital.
Women and men aged 18 and older with a large-volume tumor exceeding 150 ml and an indication for radiation therapy are eligible to participate in this study.
Facts
- What condition: solid tumors
- Cancer characteristics: large volume (over 150 ml), indication for radiation therapy
- What the study investigates: Long-term treatment data on various radiation therapy techniques
- Study objective: Structured data collection and comparison of treatment outcomes between conventional and spatially fractionated radiation therapy
- Study duration: Routine follow-up approximately four to six weeks after the end of therapy and subsequently every three to six months; analysis of study data will take place approximately 18 months and approximately 36 months after the study start date (September 1, 2025)
- Study characteristics: prospective observational registry study; no new therapy is being investigated (participants are selected by the treating physicians); monocenter study conducted at Heidelberg University Hospital
Trial sites
2 trial sites in Germany are listed.
Nationales Centrum für Tumorerkrankungen Heidelberg
Im Neuenheimer Feld 280, 69120 Heidelberg
RecruitingUniversitätsklinikum Heidelberg
Heidelberg
Status unknown
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.


