Study on Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone for Treating Nasal and Paranasal Sinus Cancer

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03493425

Provider View

This clinical trial is exploring whether adding chemotherapy before surgery and radiation therapy is more effective than surgery and radiation therapy alone in treating nasal and paranasal sinus cancer that can be surgically removed.

Patient Parameters

Program Overview

The purpose of this study is to compare two treatment approaches for nasal and paranasal sinus cancer that can be removed by surgery. One approach involves giving chemotherapy drugs like docetaxel, cisplatin, or carboplatin before surgery and radiation therapy to shrink the tumor and potentially preserve more normal tissue. The other approach involves surgery and radiation therapy without prior chemotherapy. Radiation therapy uses high-energy x-rays to kill cancer cells and reduce tumor size.

Description

The study has two main goals:

  1. To see if giving chemotherapy before surgery and radiation can help preserve important structures in the face, like the eye socket and skull base, in patients with advanced nasal and paranasal sinus cancer.
  2. To evaluate the overall survival of patients receiving either treatment approach.

Secondary goals include:

  • Assessing how long patients live without the cancer getting worse.
  • Checking if the eye socket can be preserved without needing major surgery.
  • Analyzing specific cancer markers and their impact on treatment outcomes.
  • Using imaging tests to predict the success of preserving facial structures and overall survival.

The study also looks at the effects of tobacco use on treatment side effects and patient symptoms, as well as efforts to quit smoking.

Participants are randomly assigned to one of two groups:

  • Group A: Undergo standard surgery followed by radiation therapy. If cancer cells are found at the edges of the removed tissue or in lymph nodes, additional chemotherapy may be given.

  • Group B: Receive chemotherapy with docetaxel and cisplatin (or carboplatin if cisplatin is not suitable) before surgery. After surgery, patients receive radiation therapy, and additional chemotherapy if needed.

After treatment, patients will have regular follow-up visits every 3 months for the first 2 years, then every 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be in good general health and able to perform daily activities.
  • Have a specific type of nasal or paranasal sinus cancer that requires surgery involving the eye socket or skull base.
  • Cancer must be at a stage where surgery is possible.
  • Must not be participating in other experimental treatments.
  • No history of severe allergic reactions to chemotherapy drugs used in the study.
  • No evidence of cancer spread to distant parts of the body.
  • Must not have received previous radiation for head, neck, or brain tumors.
  • Must not have other serious health conditions that could interfere with treatment.
  • Must have adequate blood cell counts and organ function based on recent tests.
  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
  • Must have measurable cancer that can be tracked with imaging tests.

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