Trial Title:
Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
NCT ID:
NCT00002702
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Aldesleukin
Conditions: Keywords:
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
tongue cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Primary purpose:
Treatment
Intervention:
Intervention type:
Biological
Intervention name:
aldesleukin
Intervention type:
Procedure
Intervention name:
adjuvant therapy
Intervention type:
Procedure
Intervention name:
conventional surgery
Intervention type:
Procedure
Intervention name:
neoadjuvant therapy
Intervention type:
Radiation
Intervention name:
radiation therapy
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.
Detailed description:
OBJECTIVES:
- Compare the disease-free and overall survival in patients with previously untreated
squamous cell carcinoma of the oral cavity or oropharynx treated with resection with
or without and neoadjuvant and adjuvant perilymphatic interleukin-2 (IL-2) and
radiotherapy.
- Compare the response rate in patients treated with these regimens.
- Determine the local and systemic effects of locoregional IL-2 on host-tumor
interaction and immune properties in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center and tumor stage (T2, N0-2 vs T2, N3 or T3-4, N0-3). Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients undergo induction comprising interleukin-2 (IL-2) via perilymphatic
injections to the ipsilateral myelohyoid muscle and insertion of the
sternocleidomastoid muscle on days 1-5 and 8-12. Within 10 days after the last IL-2
injection, patients undergo en bloc resection of the primary tumor and corresponding
lymphatic drainage area and pre-study margins. Beginning within 4 weeks after
surgery, patients with T2, N0-3 disease but with pathohistological evidence of node
invasion or capsular rupture of node metastasis or T3-4, N0-3 disease undergo
adjuvant radiotherapy 5 days a week for 4.5-6.5 weeks. Beginning within 4 weeks
after surgery or radiotherapy (if applicable), patients receive adjuvant IL-2 via
perilymphatic injections to the contralateral myelohyoid muscle and insertion of the
sternocleidomastoid muscle on days 1-5. Adjuvant IL-2 continues monthly for at least
1 year in the absence of disease progression.
- Arm II: Patients undergo resection and radiotherapy (if eligible) as in arm I.
Patients are followed monthly for 1 year and then every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for
this study.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Universita Degli Studi di Bari
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Contact:
Last name:
G. Cervellera, MD
Phone:
39-080-5478-660
Facility:
Name:
Cattedra di Oncologia Medica - Universita degli Studi di Cagliari
Address:
City:
Cagliari
Zip:
09042
Country:
Italy
Status:
Recruiting
Contact:
Last name:
P. Puxeddu, MD
Phone:
39-070-5109-6253
Facility:
Name:
Universita di Ferrara
Address:
City:
Ferrara
Zip:
44100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
C. Calearo, MD
Phone:
39-0532-209-296
Email:
ccv@dns.unife.it
Facility:
Name:
Universita Degli Studi di Florence - Policlinico di Careggi
Address:
City:
Florence
Zip:
50134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
O. Fini-Storchi, MD
Phone:
39-55-411739
Facility:
Name:
Universita di Torino
Address:
City:
Turin
Zip:
10126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
G. Valente, MD
Phone:
39-011-670-5955
Facility:
Name:
Azienda Sanitaria Ospedaliera Ordine Mauriziano
Address:
City:
Turin
Zip:
10128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
G. Forni, MD
Phone:
39-11-508-1111
Facility:
Name:
Ospedale San Bortolo
Address:
City:
Vicenza
Zip:
36100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
C. Curioni, MD
Phone:
39-444-993-906
Start date:
September 1992
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00002702
