Individualized Response-adaptive Radiation Dose Prescription in HNC Based on MRI

NCT05160714 | Unknown Phase 1 DMC

• 1 other identifier: 081/2021B01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 1 dose-finding study investigates the maximal tolerated dose for a subsequent phase 2 trial testing MR-guided individualized response-adaptive dose prescription in HNC.

Conditions

Head and Neck Cancer

Keywords

Radiotherapy; MR-guided Radiotherapy; dose-finding study; MR-Linac; ADC-guided response adaptive Boost

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity (DLT)

  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)

  At 3 months after radiotherapy

Secondary Outcomes (2)

• Regional tumor control

  After 6 weeks, 3 months and every 3 months up to two years

• Disease free survival

  During treatment and after 6 weeks, 3 months and every 3 months up to two years

Study Arms (1)

Adaptive SBRT Boost

EXPERIMENTAL

Dose-escalated SBRT boost to an ADC-based high risk subvolume in HNC

Radiation: Real-time ADC-guided response adaptive Boost in HNC

Interventions

Real-time ADC-guided response adaptive Boost in HNC RADIATION

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

Adaptive SBRT Boost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

UKT Radiooncology

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Simon Böke, MD

CONTACT

49 (0) 7071 29; ro-info@med.uni-tuebingen.de

Daniel Zips, MD, Prof.

CONTACT

49 (0) 7071 29; ro-info@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: December 16, 2021
• Study Start: January 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2025
• Last Updated: February 1, 2022

Record last verified: 2021-03

Locations

DE (1)