NCT00002702

Brief Summary

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for phase_3 head-and-neck-cancer

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1992

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

August 26, 2013

Status Verified

February 1, 2011

First QC Date

November 1, 1999

Last Update Submit

August 23, 2013

Conditions

Head and Neck Cancer

Keywords

stage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxtongue cancer

Outcome Measures

Primary Outcomes (4)

  • Disease-free survival at 3 and 5 years

  • Recurrence/metastasis rate at 3 and 5 years

  • Response rate

  • Local and systemic effects of treatment

Interventions

aldesleukinBIOLOGICAL
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Universita Degli Studi di Bari

Bari, 70124, Italy

RECRUITING

Cattedra di Oncologia Medica - Universita degli Studi di Cagliari

Cagliari, 09042, Italy

RECRUITING

Universita di Ferrara

Ferrara, 44100, Italy

RECRUITING

Universita Degli Studi di Florence - Policlinico di Careggi

Florence, 50134, Italy

RECRUITING

Universita di Torino

Turin, 10126, Italy

RECRUITING

Azienda Sanitaria Ospedaliera Ordine Mauriziano

Turin, 10128, Italy

RECRUITING

Ospedale San Bortolo

Vicenza, 36100, Italy

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckTongue Neoplasms

Interventions

aldesleukinChemotherapy, AdjuvantNeoadjuvant TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Giorgio Cortesina, MD

    Universita Degli Studi di Turin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1992

Last Updated

August 26, 2013

Record last verified: 2011-02

Locations

IT(7)