The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

Sponsor: University of Maryland, Baltimore

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04527900

Provider View

This study is testing a new treatment method called Upfront Intensity Modulated Proton Beam Therapy (IMPT) combined with chemotherapy for patients with advanced endometrial cancer after surgery. The goal is to see if this approach is as effective and manageable as previous treatments.

Patient Parameters

Program Overview

This phase 2 study aims to find out if a new treatment method, called Upfront Intensity Modulated Proton Beam Therapy (IMPT) combined with chemotherapy, is as effective and manageable for patients with advanced endometrial cancer after surgery as previous treatments. The study will compare the treatment compliance rate of this new method to a historical study known as GOG 258.

Description

This study is exploring a new way to treat advanced endometrial cancer after surgery. Typically, patients receive both chemotherapy and radiation therapy, but the order and combination of these treatments can vary. Some common methods include giving chemotherapy first, then radiation, or mixing them together. Recent studies suggest that using proton beam therapy, a type of radiation that targets cancer more precisely, might be beneficial. This study will test if patients can complete a full course of chemotherapy (carboplatin and paclitaxel) alongside this new type of radiation therapy, called IMPT, without significant side effects. Early data shows that this approach might reduce damage to healthy tissues like the bladder and bowel, and cause fewer side effects.

Eligibility Criteria

Inclusion Criteria

  • Must have had surgery that included a hysterectomy. Other procedures like removal of ovaries or lymph nodes are optional.
  • Cancer must be staged according to the FIGO 2009 system, based on specific clinical and pathological features.
  • Eligible patients include those with:
    • Endometrioid endometrial cancer at certain stages (IA grade 3 with extensive LVSI, IB grade 3, II, III, IVA) recommended for pelvic radiation and chemotherapy.
    • Clear cell, serous papillary carcinoma, or carcinosarcoma at stages IA-III recommended for similar treatment.
  • Must have a GOG Performance Status of 0, 1, or 2, indicating good overall health.
  • Must have adequate organ function, shown by specific blood test results.
  • Must have signed informed consent to participate.
  • Must be 18 years or older.

Exclusion Criteria

  • Patients with leiomyosarcoma.
  • Patients with significant pelvic or para-aortic lymph node disease not removed during surgery.
  • Patients with recurrent endometrial cancer needing high-dose radiotherapy or with a history of prior chemotherapy.
  • Patients who have had previous pelvic or abdominal radiation or chemotherapy for other cancers.
  • Patients with serious or uncontrolled illnesses that would prevent them from receiving the study treatment.
  • Patients expected to live less than three months.
  • Patients with FIGO 2009 Stage IVB endometrial cancer.
  • Patients with recent heart problems like a heart attack or unstable angina within the last three months.

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