Surgery and Radiation Therapy With or Without Chemotherapy in Treating Patients With Mouth Cancer

NCT00002747 | Unknown Phase 3

• 2 other identifiers: CDR0000064678CNR-012309
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if surgery plus radiation therapy is more effective with or without chemotherapy for treating mouth cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery and radiation therapy with or without chemotherapy in treating patients with stage II, stage III, or stage IV mouth cancer.

Conditions

Head and Neck Cancer

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

Interventions

cisplatin DRUG

fluorouracil DRUG

conventional surgery PROCEDURE

low-LET cobalt-60 gamma ray therapy RADIATION

low-LET photon therapy RADIATION

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Squamous cell carcinoma of the lower oral cavity eligible for resection T2 (greater than 3 cm), T3, or T4, and N0-3 M0 (UICC staging system) No requirement for postsurgical reconstruction that would impede further radiotherapy PATIENT CHARACTERISTICS: Age: 70 and under Performance status: WHO 0 or 1 Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 2,000/mm3 Platelet count at least 110,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance at least 50 mg/mL BUN no greater than 50 mg/dL Cardiovascular: No cardiopathy Other: No significant internal disease No prior malignancy except basal cell carcinoma of the skin No geographic barrier to treatment PRIOR CONCURRENT THERAPY: No prior therapy

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• R. Molinari, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  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: June 23, 2004
• Study Start: September 1, 1992
• Last Updated: September 20, 2013

Record last verified: 2007-05

Locations

IT (1)