Reduced Radiation Therapy for HPV-positive Head and Neck Cancer
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
Recruiting
N/AInterventional Study
Head-and-neck Squamous Cell Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
304 (estimated)
Sponsor
Technische Universität Dresden · Other
Who this trial is looking for
This trial is looking for patients who have had surgery for HPV-positive head and neck cancer. Participants will receive a lower dose of radiation and possibly chemotherapy based on their cancer characteristics.
Are You a Good Fit for This Trial?
You may be able to join if
I have had surgery to remove my oropharyngeal cancer.
I need follow-up radiation or chemotherapy after surgery.
I am in good overall health.
I can follow the study requirements.
I have provided written consent.
I have had neck dissection on at least the tumor side.
You may not be able to join if
I have smoked more than 30 pack-years.
I have had cancer spread to other parts of my body.
I have visible cancer left after surgery.
I did not have neck dissection.
It has been more than 7 weeks since my last surgery.
I have another serious illness that makes it hard to follow the study.
I am pregnant or breastfeeding.
I cannot follow the study rules.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 res…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
Inclusion Criteria:
* 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
* Patient's consent and written consent
* Neck dissection of at least the tumor bearing side
Additional Inclusion Criteria Arm intermediate risk (at least one of the criteria must be fulfilled):
* pT3 and R0 and / or
* histologically confirmed involvement of lymph nodes (n = 1-3) and no extracapsular extension of the lymph node metastasis
Additional Inclusion Criteria Arm high risk (at least one of the criteria must be fulfilled):
* residual tumor (R1 status) and / or
* pathologic stage T4 (pT4) status and / or
* more than 3 infected lymph nodes and / or
* extracapsular extension of at least one lymph node metastasis
Exclusion Criteria:
* 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
* interval between last operation and planned irradiation start \> 7 weeks
* contraindication against a guideline-appropriate adjuvant radiation or radiochemotherapy according to the clinical risk constellation
* tumor disease in the last five years before the beginning of the study (except basaliomas of the skin, in-situ carcinoma of the cervix uteri or breast, or tumors with similar prognosis which are considered to be very likely to be cured)
* malignant tumor disease in the head and neck region, regardless of interval and prognosis
* Pre-irradiation with risk of dose overlap
* participation in another clinical trial if further experimental therapy is necessary or the treatments/ protocols are mutually exclusive (e.g. altered chemotherapy, additional consolidation chemotherapy). Allowed is the additional participation in observation studies or supportive therapy studies.
* diseases or conditions which do not allow the person concerned to assess the nature and scope and possible consequences of the clinical trial
* pregnant or lactating women
* evidence that the participant is not expected to comply with the study protocol (e.g. lack of cooperation)
* missing written consent
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