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NCT Number: NCT05917301

Pre-operative Hypofractionated Proton Therapy

This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures.

Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.

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Key information

Conditions

Soft Tissue Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years of age)
  • Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
  • WHO/ECOG status ≤2

Exclusion criteria

  • History of prior local radiation therapy
  • Inability to tolerate treatment position for duration of simulation or treatment
  • Tumor originating in retroperitoneal location
  • Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy
  • Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
  • Confirmed pregnancy.

Treatment and study plan

hypofractionation

Radiation

This study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome.

Primary outcomes

  1. Rate of major wound complications

    Time frame: 90 days after surgery

    Number of major wound complications as defined by the CAN-NCIC-SR2 trial ("secondary operation under general or regional anaesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts), or wound management without secondary operation…[including] an invasive procedure without general or regional anaesthesia (mainly aspiration of seroma), readmission for wound care such as intravenous antibiotics, or persistent deep packing for 120 days or longer.")

Secondary outcomes

  1. Incidence of acute grade ≥3 adverse events

    Time frame: 2 years after treatment

    Rate of acute grade 3 or higher adverse events (CTCAE5)

  2. Rate of local recurrence free survival

    Time frame: 1 and 2 years after enrollment

    Number of patients without local recurrence on CT and/or MRI at specified time points.

  3. Rate of metastasis free survival

    Time frame: 1 and 2 years after enrollment

    Number of patients without metastasis on CT and/or MRI at specified time points.

  4. Rate of late grade ≥2 radiation toxicity

    Time frame: median two year follow up

    Rate of grade 2 or higher CTCAE5 adverse events associated with radiation therapy (fibrosis, lymphedema, or joint stiffness).

  5. Musculoskeletal Tumor Rating Scale scores

    Time frame: baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years

    The Musculoskeletal Tumor Rating Scale measures physical function in patients with musculoskeletal tumors. The total score for the MSTS ranges 0-30 with higher scores indicating better function.

  6. Toronto Extremity Salvage Score (TESS) scores

    Time frame: baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years

    The Toronto Extremity Salvage Score (TESS) measures physical function in patients with musculoskeletal tumors. The total score for the TESS ranges 0-100 with higher scores indicating better function.

  7. Functional Assessment of Cancer Therapy-General (FACT-G) scores

    Time frame: baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years

    The Functional Assessment of Cancer Therapy-General (FACT-G) measures quality of life for patients with cancer. The total score for the FACT-G ranges 0-108 with higher scores indicating better function.

  8. Rate of pathologic complete response

    Time frame: through study conclusion (estimated 5 years from opening)

    Pathologic complete response rate is reported as the number of patients who achieve pathologic complete response after treatment.

    As per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines:

    Complete response - no remaining viable cancer cells Moderate response - only small clusters/single cancer cells remain Minimal response - residual cancer remaining, but with predominant fibrosis Poor response - minimal/no tumor kills, extensive residual cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Curtiland Deville, MD

CONTACT

[email protected]

202-537-4788

Ryan Manuel

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Robert L. Sloan Fund for Cancer Research

Registry information

Official study title

PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma

Acronym: PRONTO

Important dates

Study start
2024
Primary completion
2030
Study completion
2032
First posted
Jun 23, 2023
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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