Health TrialsbyHealthPanel

Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery

ConditionsStage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorECOG-ACRIN Cancer Research Group

About this trial

This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

General physical condition compatible with the proposed chemotherapy and surgery

Stages T3 and T4a disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection

The surgical oncologist in each institution will determine the need for resection of the orbit OR base of skull at baseline for patients on both Arms A and B and following neo-adjuvant chemotherapy for patients on Arm B

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carboplatin

    Drug

    Given IV

  • Cisplatin

    Drug

    Given IV

  • Docetaxel

    Drug

    Given IV

  • Image Guided Radiation Therapy

    Radiation

    Undergo image guided IMRT

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo image guided IMRT

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Therapeutic Conventional Surgery

    Procedure/Surgery

    Undergo standard of care surgery

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Arm A (surgery, IMRT, cisplatin, carboplatin)Active comparator 7 interventions
Group B: Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Structure preservation rate defined as both skull base and orbit being preserved

Fisher?s exact test will be used to compare the structure preservation rate between the two arms. The comparison between the two arms for structure preservation will be conducted separately (each at one-sided 0.05 significance level).

Time frame
Up to 5 years
2

Overall survival (OS)

Log rank test will be used to compare OS between the two arms. The comparison between the two arms for OS will be conducted separately (each at one-sided 0.05 significance level).

Time frame
From date of randomization, censoring follow-up at last date of contact, assessed for up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ECOG-ACRIN Cancer Research Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now