Reducing radiation therapy for head and neck cancer patients

De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

This study is testing if cutting back on radiation for head and neck cancer patients can help reduce side effects while still keeping the cancer under control.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 508 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Erlangen-Nürnberg Medical School (other)
• Drugs / interventions: immunotherapy, radiation
• Locations: 1 site (Erlangen, Bavaria)
• Trial ID: NCT06030440 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter trial investigates whether postoperative radiotherapy can be safely reduced by eliminating radiation to the elective neck in patients with squamous cell carcinoma of the head and neck. The study will compare two groups: one receiving standard radiation treatment and another receiving targeted radiation to the primary tumor and affected lymph nodes only. The goal is to minimize long-term side effects while maintaining effective cancer control. The trial will proceed in two phases, with the first phase focusing on the rate of dependence on feeding tubes and the second phase assessing locoregional control rates.

Who should consider this trial

Good fit: Ideal candidates include adults with histologically confirmed squamous cell carcinoma of the oral cavity, larynx, or hypopharynx who have undergone surgery and meet specific criteria.

Not a fit: Patients with distant metastases or those who have had incomplete tumor resections will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the side effects of radiation therapy for patients with head and neck cancer.

How similar studies have performed: Other studies have explored similar de-intensification strategies in cancer treatment, showing promising results, but this specific approach is novel.

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)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

Where this trial is running

Erlangen, Bavaria

• Universitätsklinikum Erlangen, Strahlenklinik — Erlangen, Bavaria, Germany (RECRUITING)

Study contacts

• Principal investigator: Rainer Fietkau, Prof — Universitätsklinikum Erlangen, Radiation Oncology
• Study coordinator: Marlen Haderlein, PD

Conditions: Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Hypopharynx, Squamous Cell Carcinoma of the Oropharynx