De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Overview
- Phase
- Phase 2
- Intervention
- RT standard of care
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Enrollment
- 508
- Locations
- 1
- Primary Endpoint
- Phase II: 1-year PEG feeding tube dependence rate
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.
Detailed Description
This study aims to determine whether it is possible to achieve an individual target volume concept that eliminates elective irradiation of uninvolved lymph drainage areas while maintaining clearly defined surgical standards and using modern imaging and radiation techniques. The aim of this study is to achieve reduced late toxicity without compromising locoregional control. Patients will be randomized to: either RT to primary tumor region, regions with lymph node metastases and elective nodal irradiation (control arm) or RT to primary tumor region and regions with lymph node metastases without elective nodal irradiation (investigational arm) A two-stage design was chosen for this purpose. Phase II: A randomized phase II study whose primary endpoint is the 1-year percutaneous endoscopic gastrostomy (PEG) tube dependence rate will be performed first. Phase III: If the primary endpoint of the phase II study is met and the interim analysis shows no increase in the locoregional recurrence rate in the study/investigational arm, the study will be continued as a phase III study whose primary endpoint is the locoregional control rate.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0))
- •Surgery of primary tumor and neck dissection performed according to predefined surgical standard
- •Indication for postoperative radio(chemo)therapy
- •No lymph node metastases \> 6cm
- •Lymph node metastases in not more than 3 lymph node level
- •No distant metastases (cM0)
- •Age ≥ 18 years, no upper age limit
- •Eastern Cooperative Oncology Group (ECOG) ≤ 2
- •Patients who understood protocol contents and are able to behave according to protocol
- •Signed study-specific consent form prior to therapy
Exclusion Criteria
- •macroscopic incomplete resection R2
- •Distant metastases (cM1)
- •Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)
- •Lymph node metastases in \> 3 lymph node level
- •pregnant or lactating/nursing women
- •fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment
- •Any condition potentially hampering compliance with the study protocol and follow-up schedule
- •On-treatment participation on other clinical therapeutic trials
- •Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction))
- •Patients who have contraindication for MRI and CT with contrast agent (both)
Arms & Interventions
Control Arm
postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation
Intervention: RT standard of care
Investigational Arm
postoperative radiotherapy of the head and neck region without elective nodal irradiation
Intervention: Eliminating RT to the elective neck
Outcomes
Primary Outcomes
Phase II: 1-year PEG feeding tube dependence rate
Time Frame: PEG-dependent 1 year after radiotherapy
observe change of PEG-dependence due to different target volumes
Phase III: Time to local relapse
Time Frame: From the date of randomization until the date of observation of local relapse or the date of last observation if no LR occurred, whichever came first (assessed up to 26 months)
difference between the date of randomization and the date of observation of local relapse (LR), or the date of last observation if no LR occurred (censored observation)
Secondary Outcomes
- Distant-metastasis-free survival(through study completion, an average of 26 months)
- Cause of death (tumor-related, not tumor-related)(through study completion, an average of 26 months)
- Acute toxicity according to Common Terminology Criteria (CTC) version 5.0(up to 2 months)
- Late toxicity according to CTC version 5.0(up to 24 months)
- Overall survival (OS)(up to 26 months)
- Disease-free survival(up to 26 months)