About this trial
In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+) postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and / or residual tumor (R1-Status) after resection. Oropharyngeal cancer caused by HPV (human papillomavirus 16) is a distinct subgroup with a known sensitivity to radiotherapy (RTx) or radiochemotherapy (RCTx). Additionally a superior outcome after R(C)Tx over HPV negative patients was shown for patients treated with primary or adjuvant RCTx. To date it is unknown if the total dose of the radiotherapy can be safely reduced with the aim to decrease the therapy associated late effects.
Patients with a HPV associated carcinoma that take part in the study will be treated with a reduced radiotherapy dose, chemotherapy will be prescribed based on clinical factors (number of affected lymph node, presence of extracapsular spread or residual tumor). Radiation dose will be reduced in two steps.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Condition after surgical removal of a squamous cell carcinoma of the oropharynx and adequate lymph node dissection
Indication for adjuvant radiotherapy or radiochemotherapy in the interdisciplinary tumor board
Good general state (ECOG performance status 0 or 1)
Adequate compliance to ensure closely follow-up
Disqualifiers
Patients with a cumulative nicotine abuse > 30 packyears. These patients are not included in the intervention arms, but are always included in the observation arms (regardless of HPV status).
radiologically presumed or histologically confirmed distant metastasis
R2 resection or macroscopically visible residual tumor after surgery
no neck dissection
Trial design
Sequential
Treatments tested in this trial
De-escalation radio(chemo)therapy - Level 1
Radiation55/ 59,4 Gy (intermediate / high risk group)
De-escalation radio(chemo)therapy - Level 2
Radiation48,4/ 55 Gy (intermediate / high risk group)
Standard radio(chemotherapy)
Radiation60/ 66 Gy (intermediate / high risk group)
Treatment groups
Trial outcomes
Primary outcomes
rate of locoregional recurrences
measured from the last day of treatment
Secondary outcomes
overall survival
measured from the last day of treatment
acute toxicity
The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.
late toxicity
The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.
quality of life of cancer patients
The assessment of quality of life (QoL) is carried out using the EORTC quality of life questionnaire (QLQ) C30. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit. QOL will be measured as change from baseline over time.
Sponsors and contacts
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Technische Universität Dresden
Lead sponsor
German Cancer Research Center
Collaborator
National Center for Tumor Diseases (NCT) Dresden
Collaborator
National Center for Tumor Diseases, Heidelberg
Collaborator
Radiation Oncology Working Group of the German Cancer Society
Collaborator