Clinical trial · Interventional
Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
Multicentre Randomised Trial of Inductive and Adjuvant Perilymphatically Injected Proleukin (rlL-2) in The Treatment of Operable Primary Squamous Cell Carcinoma of The Oral Cavity and Oropharynx
- 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: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells of the mouth or oropharynx. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not known whether giving interleukin-2 with surgery and radiation therapy is more effective than surgery and radiation therapy alone. PURPOSE: This randomized phase III trial is studying surgery and radiation therapy alone to see how well they work compared to surgery, radiation therapy, and interleukin-2 in treating patients with cancer of the mouth or oropharynx.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| aldesleukin | Biological | Aldesleukin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Disease-free survival at 3 and 5 years
- measure
- Recurrence/metastasis rate at 3 and 5 years
- measure
- Response rate
- measure
- Local and systemic effects of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven squamous cell carcinoma of the oral cavity or oropharynx * Operable, primary, unilateral, stage T2-4, N0-3, M0 disease * No high probability of bilateral lymphatic spread (requirement for bilateral neck dissection) * No tumor involvement of the following sites: * Pterygopalatine fossa * Carotid artery * Maxillary sinus * Facial skin * Anterior floor of the mouth * Base of the tongue infiltrating more than 1 cm * Measurable or evaluable disease by physical exam and/or noninvasive imaging PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * ECOG 0-2 OR * Karnofsky 70-100% Life expectancy: * More than 3 months Hematopoietic: * WBC at least 4,000/mm3 * Platelet count at least 60,000/mm3 * Hematocrit at least 30% Hepatic: * Bilirubin normal * Hepatitis B surface antigen negative Renal: * Creatinine normal Cardiovascular: * No congestive heart failure * No uncontrolled hypertension * No coronary artery disease * No serious arrhythmia * No evidence of prior myocardial infarction on ECG (stress test required if in doubt) Other: * HIV negative * No autoimmune disease * No contraindications to pressor agents * No serious infection requiring antibiotics * No other concurrent primary malignancy * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior or other concurrent immunotherapy Chemotherapy: * No prior or concurrent chemotherapy Endocrine therapy: * No prior or concurrent hormonal therapy * No concurrent corticosteroids Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics * No prior major organ allografts Other: * No other prior therapy * No other concurrent investigational drugs, agents, or devices * No concurrent nonsteroidal antiinflammatory drugs, ranitidine, cimetidine, or coumarin
References
Publications (0)
Data not yet available