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Treatment of Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT01086826 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2015-01-26

No results posted yet for this study

Summary

This is a randomized multicenter open label phase III factorial trial evaluating the 3 years OS in patients with locally advanced squamous cell carcinoma of head and neck treated with locoregional treatment (radiotherapy plus concomitant chemotherapy or cetuximab) with or without neoadjuvant chemotherapy.

Conditions

Interventions

DRUG

RT+CDDP/5-FU

RT=70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) CDDP: 20 mg/m2/day as 30 minutes IV infusion from day 1 to day 4 5-FU: 800 mg/m2/day for 4 days Both drugs will be administered during weeks 1 and 6 of irradiation, starting from day 1 of radiotherapy.

DRUG

RT+CETUXIMAB

RT= 70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) Cetuximab= 400 mg/m2 as first dose.Subsequent doses of 250 mg/ m2, weekly, for 7 times.

DRUG

INDUCTION CTx(TPF)+(RT+CDDP/5-FU)

INDUCTION CTx(TPF):docetaxel 75 mg/m² + CDDP 80mg/m² + 5-FU 800 mg/m²/day from day 1 to day 4 will begin after the end of cisplatin infusion on day 1.Every 3 weeks. concomitant CTx= CDDP 20 mg/m2/day + 5-FU 800 mg/m2/day RT= 70 Gy(2 Gy x1/day, 5 days per week for 7 weeks)

DRUG

INDUCTION CTx(TPF)+(RT+CETUXIMAB)

INDUCTION CTx(TPF):docetaxel 75 mg/m² + CDDP 80mg/m² + 5-FU 800 mg/m²/day from day 1 to day 4 will begin after the end of cisplatin infusion on day 1.Every 3 weeks. RT= 70 Gy(2 Gy x1/day, 5 days per week for 7 weeks) CETUXIMAB= 400 mg/m2 as first dose. Subsequent doses of 250 mg/ m2, weekly, for 7 times.

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Associazione Volontari Pazienti Oncologici

    lead OTHER

Principal Investigators

  • Maria Grazia Ghi, MD · Ospedale SS Giovanni e Paolo - Venezia, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2014-04-30
Completion
2014-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01086826 on ClinicalTrials.gov