Individualized Response-adaptive Radiation Dose Prescription in HNC Based on MRI (MRL-02)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05160714 |
Recruitment Status :
Recruiting
First Posted : December 16, 2021
Last Update Posted : February 1, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Radiation: Real-time ADC-guided response adaptive Boost in HNC | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Dose-finding phase 1 trial with four dose levels and 3+3 design: 12 patients if no DLT occurs up to 24 patients if 1 DLT per dose-level occurs. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Individualized Response-adaptive Radiation Dose Prescription in HNC Based on MRI - Real-time ADC-guided Response Adaptive Boost in HNC - "Individuelle MR-basierte Dosisverschreibung Bei Kopf-Hals-Tumoren - ADC-basierter Adaptiver Boost" |
Actual Study Start Date : | January 1, 2022 |
Estimated Primary Completion Date : | March 30, 2023 |
Estimated Study Completion Date : | March 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Adaptive SBRT Boost
Dose-escalated SBRT boost to an ADC-based high risk subvolume in HNC
|
Radiation: Real-time ADC-guided response adaptive Boost in HNC
40 Gy in 20 fractions over 5 weeks (Monday to Thursday) to the adjuvant neck, simultaneous integrated boost with 56 Gy in 20 fractions in 5 weeks to the low-risk macroscopic tumor. Once weekly Dose-escalated SBRT adaptive boost to an ADC-based high risk subvolume with graduated dose levels of 5x5 Gy, 5x5.5 Gy, 5x6 Gy, 5x6.5 Gy |
- Dose limiting toxicity (DLT) [ Time Frame: At 3 months after radiotherapy ]Dose limiting toxicity (DLT): any acute and late grade 4 or 5 related to the intervention, ≥ grade 3 CTC v.5. oral mucositis at 3 months after radiotherapy (persistent mucosal ulceration or inflammation in the high dose region with severe pain; interfering with oral intake; limiting self-care ADL)
- Regional tumor control [ Time Frame: After 6 weeks, 3 months and every 3 months up to two years ]Regional tumor control will be measured by clinical H&N examinations at six weeks and then every three months up to two years. Imaging follow-up includes MRI at 6 weeks and 3 months, FDG-PET CT at 3 months and further CTs every 3 month.
- Disease free survival [ Time Frame: During treatment and after 6 weeks, 3 months and every 3 months up to two years ]Clinical H&N examinations at six weeks and then every three months up to two years, including MRI at 6 weeks and 3 months, FDG-PET CT at 3 months and further CTs every 3 month.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: older than 18 years
- WHO (ECOG) performance status 0-2
- Histological proven HNC (squamous cell carcinoma)
- HPV negative tumors or high risk HPV positive tumors
- Stage III - IVB HNC of the hypopharynx, oropharynx and oral cavity according to UICC and AJCC guidelines
- Tumor extension and localization suitable for radiochemotherapy with curative intent
- Simultaneous standard chemotherapy with cisplatin applicable (no contra-indications)
- Dental examination and -treatment before start of therapy
- For women with childbearing potential and men in reproductive ages adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Exclusion Criteria:
- Refusal of the patients to take part in the trial
- Presence of distant metastases (UICC stage IVC)
- HPV positive tumors UICC Stage III with T1/2 N3, despite of smoking status
- Previous radiotherapy in the head and neck region
- Second malignancy that is likely to require treatment during the trial intervention or follow-up period or that, in the opinion of the physician, has a considerable risk of recurrence or metastases within the follow-up period
- Serious disease or medical condition with life expectancy of less than one year
- Participation in competing interventional trial on cancer treatment
- Patients who are not suitable for radiochemotherapy
- Pregnant or lactating women
- Patients not able to understand the character and individual consequences of the trial
- Nasopharyngeal and glottis laryngeal carcinomas
- Patients with contraindications for magnet-resonance tomography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05160714
Contact: Simon Böke, MD | 49 (0) 7071 29 ext 82165 | ro-info@med.uni-tuebingen.de | |
Contact: Daniel Zips, MD, Prof. | 49 (0) 7071 29 ext 82165 | ro-info@med.uni-tuebingen.de |
Germany | |
UKT Radiooncology | Recruiting |
Tübingen, BW, Germany, 72076 | |
Contact: Simon Böke, MD +49 7071 29 ext 82165 roinfo@med.uni-tuebingen.de |
Responsible Party: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT05160714 |
Other Study ID Numbers: |
081/2021B01 |
First Posted: | December 16, 2021 Key Record Dates |
Last Update Posted: | February 1, 2022 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Radiotherapy MR-guided Radiotherapy dose-finding study MR-Linac ADC-guided response adaptive Boost |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |