Clinical trial · Interventional
Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.
Effectiveness of Adjuvant Radiotherapy in Patients With Oropharyngeal and Floor of Mouth Squamous Cell Carcinoma and Concomitant Histological Verification of Singular Ipsilateral Cervical Lymph Node Metastasis (pN1-state)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiotherapy with or without adjuvant chemotherapy represents an important column of modern therapy in advanced squamous cell originated tumours of the head and neck. However to date no studies are available which study the effectiveness of radiotherapy in patients with resected small tumours (T1, T2) and concomitant ipsilateral metastasis of a single lymph node (pN1) for general treatment recommendation. The present study is designed as non-blinded, prospective, multicenter randomized controlled trial (RCT) for comparison of overall-survival as primary clinical target in patients receiving radiation therapy vs. patients without adjuvant radiation following curative intended surgery. Aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (radiation/non-radiation. Secondary clinical endpoints are as follows: Incidence and time to tumor relapse (locoregional relapse, lymph node involvement and metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H\&N 35 module) and time from operation to orofacial rehabilitation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- no irradiation
- description
- Patients within this arm only receive curative intended radical surgery
- type
- ACTIVE_COMPARATOR
- label
- Radiation
- description
- Patients receive radiation within 6 weeks after curative intended radical surgery.
- interventionNames
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- Primary study object: overall survival
- timeFrame
- 9 years
- description
- The objective of the clinical study will be to investigate two different patient groups (irradiated/unirradiated) with pT1/2 primary and verification of a singular ipsilateral lymph node metastasis in parallel design in order to evaluate the possible benefit of radiation therapy. The following null hypothesis forms the basis of the present study: Radiation therapy will have no influence on the overall survival in patients with pT1/2, pN1 primary tumor. First patients will be observed for 9 years, last patient in will be followed-up for 5 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histological diagnosis of a primary squamous cell carcinoma of the oral cavity or the oropharynx * maximum tumor diameter less than 4 cm in the pathohistological specimen irrespective of histological grading (pT1 or pT2) * concomitant histological verification of a singular ipsilateral lymph node metastasis less than 3cm in diameter (pN1) without penetration of the lymph node´s capsule and without presence of invasion of lymphatic vessels (lymphangiosis carcinomatosa) * radical resection of the tumor within adequate resection margins (R0) * written informed consent from the patient * adequate performance status ECOG Index ≤ 2 Exclusion Criteria: * an age less than 18 years old * pregnant women * reported drug addiction * intake of remedies with potential influence on compliance or impaired judgment * patients with mental disorders or conceivable physical, familial or job related embarrassments which may preclude the patient to realize the study schedule * inadequate performance status ECOG Index \> 2
References
Publications (1)
- BACKGROUNDMoergel M, Jahn-Eimermacher A, Krummenauer F, Reichert TE, Wagner W, Wendt TG, Werner JA, Al-Nawas B. Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design. Trials. 2009 Dec 23;10:118. doi: 10.1186/1745-6215-10-118. PMID 20028566