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Adult Soft Tissue SarcomaPhase 3NCT02565498

Preoperative vs Postoperative IMRT for Extremity/Truncal STS

A Phase 3 study testing Preoperative intensity modulated radiation therapy and Postoperative intensity modulated radiation therapy in people with Adult Soft Tissue Sarcoma, run by Mount Sinai Hospital, Canada at 8 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is designed to determine if preoperative image guided radiation therapy (IGRT) delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in similar short-term wound healing complications as surgery followed by postoperative IGRT in patients with extremity or truncal soft… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Soft Tissue Sarcoma
What is being tested?
Preoperative intensity modulated radiation therapy and Postoperative intensity modulated radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
8 sitesin 3 countries
Study dates
Jun 2016to May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven soft tissue sarcoma of the extremity or trunk following review by local reference pathologist.
  • Deemed appropriate for preoperative or postoperative radiotherapy and conservative surgery following patient assessment by a radiation oncologist and surgical oncologist.
  • Lesion is primary or locally recurrent. Patient may have undergone excisional biopsy with positive margins at a referring hospital and are eligible following discussion among the surgical oncologists and radiation oncologists that IMRT is an acceptable treatment for that case.
  • Eastern Cooperative Oncology Group (ECOG) score 0-3
  • Patient is aged 18years or older.
  • Patient is able to provide informed consent
  • Patient is available for treatment and follow-up.

Who cannot join

  • Benign histology.
  • Prior malignancy within the previous five years or concurrent malignancy with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in-situ of the cervix.
  • Prior radiotherapy to the target site
  • Planned chemotherapy for (neo)adjuvant treatment
  • Conservative surgery to the target site
  • Presence of regional nodal disease or unequivocal distant metastases.
  • Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Canada4 sites

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United States3 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

Other trials in United States

Belgium1 site

  • Cliniques Universitaires Saint-Luc

    Brussels

Other trials in Belgium

About this study

Official title: Phase III Study of Preoperative vs Postoperative Intensity Modulated Radiation Therapy For Truncal/Extremity Soft Tissue Sarcoma

This study is designed to determine if preoperative image guided radiation therapy (IGRT) delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in similar short-term wound healing complications as surgery followed by postoperative IGRT in patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive preoperative radiotherapy, half will receive postoperative radiotherapy.

Read the detailed description

Perioperative RT in addition to surgery is widely accepted as standard management for soft tissue sarcoma (STS) of the extremity and trunk. However, controversy remains as to whether RT should be delivered preoperatively or postoperatively. While both confer similar rates of local control, preoperative RT leads to a decrease in late tissue morbidities such as fibrosis, limb edema, joint stiffness and fracture as compared to postoperative RT. The reasons for this are likely multifactorial, but are in part related to total dose delivered (50 Gray (GY) preoperatively and 60-66 Gy postoperatively) and, based on a previous National Cancer Institute (Canada) Phase III randomized controlled trial, the much larger volume treated in the postoperative setting compared to that in the preoperative setting. The optimal radiation dose used in the postoperative setting is unknown but has been developed empirically and doses of 60-66 Gy are generally employed.However, investigators in Norway/Sweden and France have found equivalent local control rates for patients with negative surgical margins treated with 50 GY postoperativelyThe main concern with preoperative RT has centered on the risk of an increased rate of delayed wound healing and major wound complications. Although some studies suggest it may be possible to reduce the incidence of acute wound healing complications associated with pre-operative radiation than previously seen in the 2D RT era, this has yet to be tested in the phase III setting. IG-IMRT allows a much higher degree of conformality and accurate delivery of dose to the tumour while sparing surrounding normal tissue. This may allow similar rates of acute wound healing complications for pre- and postoperative RT in the treatment of STS.

Being tested
Preoperative intensity modulated radiation therapy, Postoperative intensity modulated radiation therapy
Keywords
Soft tissue sarcoma, Extremity, Preoperative radiotherapy, Postoperative radiotherapy
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative intensity modulated radiation therapyRadiation

    50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision

  • Postoperative intensity modulated radiation therapyRadiation

    Surgery followed by 50 Gy delivered in 25 fractions within 6 weeks of surgery for patients with negative margins; for patients with positive margins a boost of 16 Gy in 8 fractions will be added.

Study groups in NCT02565498
Study groupRoleWhat they receive
Preoperative Radiation Therapy (Arm A)OtherPreoperative intensity modulated radiation therapy followed by surgery
Receives: Radiation: Preoperative intensity modulated radiation therapy
Postoperative Radiation Therapy (Arm B)ExperimentalSurgery followed by postoperative intensity modulated radiation therapy
Receives: Radiation: Postoperative intensity modulated radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of acute wound healing complications

    • Secondary operations required for wound treatment (debridement, secondary closure procedures such as rotationplasty, free flaps or skin grafts);
    • Readmission to hospital for wound care;
    • Invasive procedures required for wound care (drainage of hematoma, seroma or infected wound collection);
    • Deep wound packing required at any time (deep packing defined as packing deep to dermis in an area of dehisced wound) to an area of the wound measuring at least 2 cm in length;
    • Prolonged dressing changes, including packing of the wound for greater than six weeks from wound breakdown;
    • Repeat surgery for revision of a split thickness skin graft or requirement for wet dressings for longer than four weeks. (It is permissible for a patient to protect a totally epithelialized skin graft with a dry dressing without declaring a major wound complication)
    • Use of vacuum-assisted closure (VAC)

    Measured: 120 days post surgery

Secondary outcomes (9)

  1. Acute Radiation Toxicity

    Acute radiation skin toxicity will be documented according to the Radiotherapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria.

    Measured: Once per week from the start of radiotherapy until its completion (5 weeks in total), then 1 week preop for Group 1; 4 weeks post completion of treatment for Group 2

  2. Late Radiation Toxicity- RTOG Late Radiation Morbidity

    Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.

    Measured: Every 3 months, from 3 months postop for Group 1 and 3 months post RT for Group 2, for 2 years, then 4 monthly for 1 year, then 6 monthly to 5 years.

  3. Late Radiation Toxicity- Common Toxicity Criteria

    Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the Common Toxicity Criteria v4.0

    Measured: Every 3 months, from 3 months postop for Group 1 and 3 months post RT for Group 2, for 2 years, then 4 monthly for 1 year, then 6 monthly to 5 years.

  4. Late Radiation Toxicity- Limb Edema

    Peripheral limb edema will be documented according to the Late Limb Edema Scoring Criteria.

    Measured: Every 3 months, from 3 months postop for Group 1 and 3 months post RT for Group 2, for 2 years, then 4 monthly for 1 year, then 6 monthly to 5 years.

  5. Limb Function

    Limb function will be documented according to the Musculoskeletal Tumor Society Rating Scale.

    Measured: Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop.

  6. Patient function

    Patient function will be documented according to the patient completed Toronto Extremity Salvage Score (TESS)

    Measured: Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop.

  7. Overall Survival

    Overall patient survival in months during the study period

    Measured: Surgery Date until 5 years postoperative or death, whichever occurs first

  8. Local recurrence-free survival

    Patient survival without a local recurrence in months during the study period.

    Measured: Surgery date until 5 years postoperative or local recurrence, whichever occurs first.

  9. Metastasis-free survival

    Patient survival without systemic metastases in months during the study period.

    Measured: Surgery date until 5 years postoperative or systemic recurrence, whichever occurs first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2015 (estimated)
  2. Study startJun 2016
  3. Primary completionOct 2024 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02565498
Sponsor's protocol ID
OCREB # 15-070
Status last verified
Feb 2024
First submitted
18 Sep 2015
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Preoperative intensity modulated radiation therapy and Postoperative intensity modulated radiation therapy in people with Adult Soft Tissue Sarcoma, run by Mount Sinai Hospital, Canada at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada, United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of acute wound healing complications (time frame: 120 days post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02565498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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