The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

Last updated: May 6, 2024
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

2

Condition

Pelvic Cancer

Endometrial Cancer

Vaginal Cancer

Treatment

carboplatin and paclitaxel

pelvic IMPT (Intensity Modulated Proton Therapy)

Clinical Study ID

NCT04527900
HP-00092397
  • Ages > 18
  • Female

Study Summary

A phase 2 study with the primary objective of testing treatment compliance of Upfront Intensity Modulated Proton Beam Therapy (IMPT) and Concurrent Chemotherapy (UPPROACH) for Post-operative Treatment in Loco-regionally Advanced Endometrial Cancer is non-inferior to the historic compliance rate of the chemoradiation arm of GOG 258 study

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Surgery must have included a hysterectomy. Bilateral salpingo-oophorectomy, pelviclymph node sampling, para-aortic lymph node sampling, and omentectomy are optional
  2. Patients will be staged according to FIGO 2009 staging system. Eligibility is definedbased on clinical-pathologic features.
  3. Patients with endometrioid endometrial cancer with the following:
  • Stage IA grade 3 with extensive LVSI
  • Stage IB grade 3
  • Stage II
  • Stage III (A, B, and C)
  • Stage IVA who are recommended adjuvant whole pelvic RT (+/- lower para-aortic upto renal hilum) and systemic chemotherapy.
  1. Patients with clear cell, serous papillary carcinoma, or carcinosarcoma with stagesIA-III who are recommended adjuvant whole pelvic RT (+/- lower para-aortic up to renalhilum) and systemic chemotherapy.
  2. Patients with a GOG Performance Status of 0, 1, or 2
  3. Patients with adequate organ function, reflected by the following parameters:
  • WBC ≥ 3000/mcl
  • Absolute neutrophil count (ANC) ≥ 1000/mcl
  • Platelet count ≥ 100,000/mcl
  • SGOT, SGPT, and alkaline phosphatase ≤ 2.5 X upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 X ULN
  • Creatinine ≤ institutional ULN (if serum creatinine > ULN, estimated GFR ≥ 45ml/min)
  1. Patients who have signed an approved informed consent and authorization permittingrelease of personal health information
  2. Patients must be 18 years of age or older

Exclusion

Exclusion Criteria:

  1. Patients with leiomyosarcoma
  2. Patients with clinically significant pelvic or para-aortic nodal disease, onpost-surgery CT scan, that was not dissected and would require higher boost dose
  3. Patients with recurrent endometrial cancer with gross nodal or vaginal diseaserequiring high dose radiotherapy, or history of prior chemotherapy
  4. Patients with a history of prior pelvic/abdominal RT or with history of prior cancertreatment that contraindicates this protocol therapy including history of priorchemotherapy for any other malignancy.
  5. Patients with a history of serious co-morbid illness or uncontrolled illnesses thatwould preclude protocol therapy
  6. Patients with an estimated survival of less than three months
  7. Patients with FIGO 2009 Stage IVB endometrial cancer
  8. Patients with a history of myocardial infarction, unstable angina, or uncontrolledarrhythmia within 3 months from enrollment

Study Design

Total Participants: 21
Treatment Group(s): 2
Primary Treatment: carboplatin and paclitaxel
Phase: 2
Study Start date:
February 23, 2021
Estimated Completion Date:
September 01, 2028

Study Description

While there is a consensus that both adjuvant ChT and RT benefit patients with respect to locoregional and distant control, the sequencing of these therapies varies between institutions. Common approaches include sequential treatment, with 4-6 cycles of ChT followed by RT, sandwich therapy with RT sandwiched between 3 cycles of ChT, or concurrent CRT. Small retrospective studies have shown a benefit with respect to PFS and OS in the sandwich approach, however this has not been replicated in larger studies.

In more recent years, proton beam therapy (PBT) has become an increasingly common modality for the treatment of uterine malignancies and is capable of even more precise dose distributions than photon-based RT due to intrinsic properties of these much heavier particles. Dosimetric/planning studies from other institutions confirm the significant reduction of dose to critical normal tissues like bladder, bowel, rectum, and bone marrow.

Preliminary data from the University of Maryland Medical Center has suggested that IMPT using pencil beam scanning is feasible in patients with endometrial cancer, with only 10% of patients developing grade 2 GI toxicity and no patients developing ≥ grade 3 GI or GU toxicities (abstract under review).

The investigators would like to test the hypothesis that in the postoperative setting, patients with advanced endometrial cancer will be able to complete a course of full dose ChT

  • carboplatin and paclitaxel - concurrent with upfront pelvic IMPT.

Connect with a study center

  • Maryland Proton Treatment Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • UMMC

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Central Maryland Radiation Oncology

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • Baltimore Washington Medical Center

    Glen Burnie, Maryland 21061
    United States

    Active - Recruiting

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