Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Preoperative stereotatic radiosurgery following resection of brain metastases after 1-7 days

Intraoperative stereotactic radiotherapy after resection of brain metastases

Resection of brain metastases following stereotactic radiotherapy after 2-6 weeks

Preoperative Radiotherapy

Intraoperative Radiation

Postoperative Radiotherapy

Tanja Eichkorn, MD

Adriane Hommertgen, PhD

Juergen Debus, Prof. Dr. Dr.

Adriane Hommertgen, Dr. med.

Jürgen Debus, Prof.

Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life.

Combining surgery and radiotherapy for resectable brain metastases is standard of care but there is a lot of controversy on which kind of radiotherapy is best suitable. Recently, first volumetric in-silico analyses point to theoretical advantages of neoadjuvant stereotactic radiotherapy of brain metastases. Special about this trial is the direct comparison between the three currently discussed radiotherapy options for resectable brain metastases: Neoadjuvant stereotactic radiotherapy, intraoperative radiotherapy and adjuvant stereotactic radiotherapy.

This trial approach allows for detailed comparison of resected tissue samples, cerebrospinal fluid and blood of all patient groups. So, the investigators will investigate biomaterial of recently irradiated (neoadjuvant and intraoperative arms) and non-irradiated (adjuvant arm) tissue. All this prompts the main issues of the explorative randomized controlled phase 2 RADCAV trial: Is there a difference between neoadjuvant stereotactic radiotherapy vs. intraoperative radiotherapy vs. adjuvant stereotactic radiotherapy regarding the factors immune profiling, dosimetry, efficacy and toxicity. It can be hypothesized that the resected tissue differs between recently irradiated and non-irradiated brain metastases, for example regarding different histopathologic and molecular pathologic markers including immune environment, markers for cell death and markers for tumor invasion. Are there histopathologic and molecular pathologic markers of tumor cell response and prognosis so the investigators can better understand the effects of irradiation on metastatic brain tissue? And are there relevant differences in dosimetry that put patients at different risks for efficacy and toxicity?

Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases

Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases - A Prospective Randomized Explorative Phase II Trial

number of patients without progresion according to RANO-BM

events of tumor progression or recurrence in the area of 1cm surrounding the resection cavity and surrounding the surgical access

University Hospital Heidelberg

Department Director

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects.

The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.

Directional Brachytherapy Source Implant

Kristy Perez

Kristy Perez, PhD

Zachary Miller

Dian Wang, MD

Colleen Valenti, OCN

Paul Crossan, MD

Marc Mesleh, MD

Joshua Meyer, MD

Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.

Dose escalation Phase I followed by a feasibility trial in Phase II

Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer

Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.

Patients will be monitored for one year to determine the local cancer recurrence rate

2 year survival rates for patients post surgery and CivaSheet radiation treatment

Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory

Length of hospital stay will be monitored to determine if CivaSheet radiation treatment alters the typical length of hospital stay for patients after surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases	NCT05871307	Brain Metastase... Radiotherapy	Preoperative Ra... Intraoperative ... Postoperative R...	18 Years -	University Hospital Heidelberg
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source	NCT02843945	Pancreatic Canc...	Directional Bra...	18 Years -	CivaTech Oncology

Spots Global Cancer Trial Database for intraoperative radiation