Clinical trial · Interventional
Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor
Randomized Phase III Study On The Selection Of The Target Volume In Postoperative Radiotherapy For Cervical Lymph Node Metastases Of Squamous Cell Carcinoma From And Unknown Primary (CUP)
- 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)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which regimen of radiation therapy is more effective in treating patients who have metastases to the lymph nodes in the neck. PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have metastases to the lymph nodes in the neck from an unknown primary tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of Unknown Primary | Carcinoma of Unknown Primary | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Selective irradiation
- description
- Irradiation of the ipsilateral level I - V of the neck up to a dose of 60 Gy (30x2Gy in 6 weeks).
- interventionNames
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Extensive irradiation + ipsilaterals levels
- description
- Irradiation on the whole mucosa of the larynx, hypopharynx, oropharynx and nasopharynx, and on both sides of the neck (levels I -V) up to a prophylactic dose of 50 Gy (25 x 2 Gy in 5 week).Irradiation of the ipsilateral level I - V of the neck should continue with an additional 10 Gy boost for a total dose of 60 Gy (30 x 2 Gy in 6 weeks).
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma in cervical lymph node metastasis from an unknown primary tumor * Histopathological grade WHO 1-3 * Pathological stage N1, N2a, N2b, or N3 * No N2c (i.e., bilateral metastatic nodes) * No single node in supraclavicular fossa or submandibular area * No evidence of primary tumor in head and neck, lung, esophageal, or other site * Prior radical, radical modified, or extended radical dissection within the past 8 weeks * Selective neck dissection allowed (surgeon must justify why standard procedure was not performed) * No node excision alone * R0 or R1 disease after dissection * No distant metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Able and willing to complete quality of life questionnaires * No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix * No psychological, familial, sociological, or geographical condition that would preclude study compliance * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Concurrent chemotherapy allowed Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics Other * No other prior therapy for carcinoma of unknown primary except neck dissection
References
Publications (0)
Data not yet available