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Induction Chemotherapy Followed by Surgery for Locally Advanced Head and Neck Cancer

NCT02760667 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-06-27

No results posted yet for this study

Summary

The objective of this study is to assess the efficacy of induction chemotherapy followed by transoral surgical treatment and neck dissection, in definitive management of moderately advanced oropharyngeal squamous cell carcinoma. The surgical treatment will carry out Transoral Robotic Surgery (TORS) or Transoral Laser Microsurgery (TLM) for the primary tumor, and neck dissection for the management of cervical lymph nodes.

The primary outcome measure will be disease specific survival (DSS). The secondary oncologic outcome measures will be locoregional control, relapse free survival, overall survival, and Quality of Life (QOL).

Conditions

Interventions

DRUG

Cisplatinum

Cisplatin 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase

DRUG

Docetaxel

Docetaxel 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase

DRUG

Carboplatin

Carboplatin AUC=5 every 3 weeks for a maximum of 3 cycles during the induction phase (if subject are unable to tolerate cisplatin)

PROCEDURE

Transoral Robotic Assisted Surgery

TORS will be performed for the patients who responded to the induction treatment (80% reduction)

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Principal Investigators

  • Robert S Siegel, M.D. · George Washington University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02760667 on ClinicalTrials.gov