De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Recruiting
Phase 2Phase 3Interventional Study
Squamous Cell Carcinoma of the Oral CavitySquamous Cell Carcinoma of the LarynxSquamous Cell Carcinoma of the HypopharynxSquamous Cell Carcinoma of the Oropharynx
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
508 (estimated)
Sponsor
University of Erlangen-Nürnberg Medical School · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0))
2. Surgery of primary tumor and neck dissection performed according to predefined surgical standard
3. Indication for postoperative radio(chemo)therap…
Inclusion Criteria:
1. Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0))
2. Surgery of primary tumor and neck dissection performed according to predefined surgical standard
3. Indication for postoperative radio(chemo)therapy
4. No lymph node metastases \> 6cm
5. Lymph node metastases in not more than 3 lymph node level
6. No distant metastases (cM0)
7. Age ≥ 18 years, no upper age limit
8. Eastern Cooperative Oncology Group (ECOG) ≤ 2
9. Patients who understood protocol contents and are able to behave according to protocol
10. Signed study-specific consent form prior to therapy
11. Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications)
Exclusion Criteria:
1. macroscopic incomplete resection R2
2. Distant metastases (cM1)
3. Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)
4. Lymph node metastases in \> 3 lymph node level
5. pregnant or lactating/nursing women
6. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment
7. Any condition potentially hampering compliance with the study protocol and follow-up schedule
8. On-treatment participation on other clinical therapeutic trials
9. Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction))
10. Patients who have contraindication for MRI and CT with contrast agent (both)
11. Prior (\> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage
12. History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease
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