Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer

Locally Advanced Head-and-Neck Cancer Clinical Trial

— CARE  

Official title:

Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer: A Phase-II Study to Evaluate Toxicity and Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185974
• Other study ID #: RADONK-CARE-2018
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: University Hospital Heidelberg
• Contact: Sebastian Adeberg, PD
• Phone: 49 622156
• Email: sebastian.adeberg[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After multimodal therapy of head-and-neck tumors, patients often develop local recurrence, locally progressive disease or second primary tumors. In this highly pre-treated patient cohort, therapeutic options are limited. Patients that are not candidates for salvage surgery may benefit from re-irradiation. Despite recent technical advances, re-irradiation is associated with severe side effects. Carbon ion Re-Radiotherapy (reCIRT) has shown encouraging results in retrospective analyses with moderate toxicity.

In the current Phase-II CARE-trial, reCIRT and conventional photon re-irradiation in patients with recurrent or progressive locally advanced head-and-neck cancer will be assessed regarding toxicity/ safety, local progression-free survival, overall survival and quality-of-life.

Description:

The incidence of head-and-neck cancer worldwide amounts to around 550.000 cases per year, with male patients affected significantly more often. Common risk factors are smoking, alcohol, viral infections, immunodeficiency or genetic factors. Locally advanced head-and-neck tumors can lead to severe symptoms such as dysphagia, cachexia and tumor pain with a significant decrease of the quality-of-life. The prognosis depends on multiple factors such as TNM-staging, tumor volume, histology, general condition, age and smoking. Further risk factors are positive resection margins, extracapsular extension and perineural invasion. While metastatic spread significantly decreases overall survival, the life-limiting problem in patients with head-and-neck cancer is locally invasive and destructive tumor growth leading to a decrease of the performance status and quality of life. After multimodal therapy of locally advanced head-and-neck tumors, around 30 - 50% of patients will develop local recurrence or locally progressive disease and up to 8% of patients with HNSCC will develop a second primary tumor in the head-and-neck .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Locally recurrent / progressive head-and-neck cancer after initial radiation therapy

• Microscopic or macroscopic tumor after salvage surgery

• Indication for re-irradiation

• Completed wound healing after surgical intervention

• Karnofsky-Performance-Score = 60

• Age = 18 years

• Written informed consent (must be available before enrolment in the trial)

• Ability of subject to understand character and individual consequences of the trial

• For women with childbearing potential, (and men) adequate contraception

• Submission of previous radiotherapy records

Exclusion Criteria:

• Re-irradiation of malignancy in the larynx

• Diagnosed plasmocytoma, sarcoma or chordoma

• Previous re-irradiation in-field

• Time interval < 6 months after initial radiotherapy

• Distant metastases (except pulmonary metastases)

• Patients who have not recovered from acute toxicities of prior therapies

• Refusal of the patients to take part in the study

• Pregnant or lactating women

• Known carcinoma <5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy

• Participation in another clinical study or observation period of competing trials, respectively

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Locally Advanced Head-and-Neck Cancer

Intervention

Radiation:
• C12 re-irradiation
51 Gy(RBE) or 54 Gy
• Photon re-irradiation
54 Gy(RBE) or 60 Gy

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg, Radiation Oncology	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of carbon ion re-irradiation	the rate of patients with an acute/subacute toxicity CTCAE v5.0 = grade 3	6 month
Primary	toxicity of carbon ion re-irradiation	the rate of patients with an acute/subacute toxicity CTCAE v5.0 = grade 3	6 month
Secondary	progression-free survival	Local progression-free survival	12 month
Secondary	Overall survival	within 12 month after re-irradiation	12 month
Secondary	Score on EORTC QLQ C30 Quality of life questionaire	EORTC (European Organization for Research and. Treatment of Cancer) QLQ (quality of life questionnaire) C30, score 1-6, high score means worse outcome	within 12 month after re-irradiation
Secondary	Score on EORTC QLQ H&N35 Quality of life questionaire	QLQ (quality of life questionnaire)-H&N (Head and neck) 35, score 1-6, high score means worse outcome	within 12 month after re-irradiation