Rectal Cancer
Conditions
Keywords
rectal cancer, HDR Brachy
Brief summary
This registry will collect data from all patients treated with the MAASTRO HDR applicator. The goal is to deepen knowledge about dose-response relationships in rectal cancer boosting, which is essential for improving future treatment approaches and patient selection.
Detailed description
Standard treatment for rectal cancer usually involves surgical removal of the tumor. Depending on the tumor's characteristics, patients may first receive neoadjuvant therapy such as radiotherapy, chemoradiotherapy, or total neoadjuvant treatment (TNT). These treatments aim to improve oncological outcomes and can lead to a complete response (CR) in about 10-40% of patients. When a CR occurs, patients may choose a watch-and-wait strategy, which avoids surgery and improves quality of life by preventing complications such as incontinence or the need for a stoma. Increasing the radiation dose improves the chance of achieving a CR. Endoluminal boost techniques-high-dose-rate (HDR) brachytherapy and contact X-ray radiotherapy (CXRT)-allow a highly localized radiation boost. CXRT has shown higher CR rates than external beam radiotherapy (EBRT) boosts (81% vs. 60%). However, widespread use of endoluminal boosting is limited by the high cost of CXRT equipment and the less favorable dose distribution of HDR brachytherapy. To overcome these limitations, MAASTRO, in collaboration with Varian Inc., developed a new HDR rectal brachytherapy applicator that delivers a dose profile similar to CXRT. The applicator has received CE certification and is now available for clinical use. A recent clinical trial confirmed that treatment with this applicator is clinically feasible. As a result, MAASTRO HDR treatment is now part of standard care. To improve understanding of treatment outcomes and optimize future strategies, a prospective observational cohort study has been initiated.This project is designed to continuously include new patients and will provide an ongoing source for multiple future studies
Interventions
None listed
Sponsors
Maastricht Radiation Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Histological proof of rectal cancer, or a strong suspicion after imaging. * Treatment with MAASTRO HDR rectal applicator * Informed consent for longitudinal observational data collection.
Exclusion criteria
* Mentally incompetent patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum. | From enrollment to the end of FU at 10 years | Number of patients with clinical complete respons. Number of patients with treatment related adverse events as assessed by CTCAE v 4.0 |
| Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view. | During treatment | Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view. |
| Duration of the application procedure. | During treatment | Duration of the application procedure. |
| Clinical complete response rate up to 5 years after treatment. | From end of treatment until 5 years after treatment | Clinical complete response rate up to 5 years after treatment. |
| Toxcity up to 3 year after treatment | From start treatment until 3 years after the end of treatment | Rectal and genitourinary toxicity scored according to CTCAE v. 5 up to 3 years after treatment |
| Disease status up to 10 years after treatment | from enrollment until 10 years after treatment | Local and locolregional recurrence rate and metastatic rate up to 10 years after treatment |
| Salvage surgery | From end of treatment until 5 years after treatment | Salvage surgery rate after treatment. |
| Overall and disease specific survival rate | from enrollment until 10 years after treatment | Overall and disease specific survival rate up to 10 year after treatment. |
| Discomfort/pain | From baseline up to 2 weeks after last fraction | Discomfort/pain during endorectal irradiation using NRS (Numeric Rating Scale 0-10) painscore |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health status | From enrollment until 5 years after treatment | Separate informed consent will be asked to measure the health status and quality of life by QLQ-C30 ( EORTC Quality of Life Questionaires, Core 30) , QLQ-CR29 ( EORTC Quality of Life Questionaires ColoRectal 29 and EQ-5D ( EuroQoL-5D) |
| Long-term rectal functional outcome | From enrollment until 5 years after treatment | Separate informed consent will be asked to measure the Long-term rectal functional outcome by LARS score (Low Anterior Resection Syndrome - scale 0-42) |
| Quality of life questionnaires | From enrollment until 5 years after treatment | Separate informed consent will be asked to measure the quality of life by QLQ-C30 ( EORTC Quality of Life Questionaires, Core 30). |
Countries
Netherlands
Contacts
CONTACTAnn Claessens
PRINCIPAL_INVESTIGATORMaaike Berbée, MD, PhD
Maastro
PRINCIPAL_INVESTIGATORBritt Hupkens, MD, PhD
Maastro
Outcome results
None listed