Preoperative vs Postoperative IMRT for Extremity/Truncal STS
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|ClinicalTrials.gov Identifier: NCT02565498|
Recruitment Status : Unknown
Verified September 2020 by Mount Sinai Hospital, Canada.
Recruitment status was: Recruiting
First Posted : October 1, 2015
Last Update Posted : September 11, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Adult Soft Tissue Sarcoma||Radiation: Preoperative intensity modulated radiation therapy Radiation: Postoperative intensity modulated radiation therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Study of Preoperative vs Postoperative Intensity Modulated Radiation Therapy For Truncal/Extremity Soft Tissue Sarcoma|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||December 2022|
Preoperative Radiation Therapy (Arm A)
Preoperative intensity modulated radiation therapy followed by surgery
Radiation: Preoperative intensity modulated radiation therapy
50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision
Experimental: Postoperative Radiation Therapy (Arm B)
Surgery followed by postoperative intensity modulated radiation therapy
Radiation: Postoperative intensity modulated radiation therapy
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.
- Incidence of acute wound healing complications [ Time Frame: 120 days post surgery ]
- 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)
- Acute Radiation Toxicity [ Time Frame: 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 ]Acute radiation skin toxicity will be documented according to the Radiotherapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria.
- Late Radiation Toxicity- RTOG Late Radiation Morbidity [ Time Frame: 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. ]Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
- Late Radiation Toxicity- Common Toxicity Criteria [ Time Frame: 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. ]Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the Common Toxicity Criteria v4.0
- Late Radiation Toxicity- Limb Edema [ Time Frame: 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. ]Peripheral limb edema will be documented according to the Late Limb Edema Scoring Criteria.
- Limb Function [ Time Frame: Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop. ]Limb function will be documented according to the Musculoskeletal Tumor Society Rating Scale.
- Patient function [ Time Frame: Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop. ]Patient function will be documented according to the patient completed Toronto Extremity Salvage Score (TESS)
- Overall Survival [ Time Frame: Surgery Date until 5 years postoperative or death, whichever occurs first ]Overall patient survival in months during the study period
- Local recurrence-free survival [ Time Frame: Surgery date until 5 years postoperative or local recurrence, whichever occurs first. ]Patient survival without a local recurrence in months during the study period.
- Metastasis-free survival [ Time Frame: Surgery date until 5 years postoperative or systemic recurrence, whichever occurs first. ]Patient survival without systemic metastases in months during the study period.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565498
|Contact: Anthony Griffin, MSc||(416) email@example.com|
|Contact: Colleen Dickie, MSc||(416) 946-2000 ext firstname.lastname@example.org|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Katerina Bubelo 617-582-8340 email@example.com|
|Contact: Patrick Boyle 617-582-8918 firstname.lastname@example.org|
|Principal Investigator: Elizabeth Baldini, MD|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Matthew Rerko 216-445-0640 email@example.com|
|Principal Investigator: Chirag Shah, MD|
|Sub-Investigator: Nathan Mesko, MD|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239-3098|
|Contact: Erh-Ting Hsu, PhD 503-494-5345 firstname.lastname@example.org|
|Principal Investigator: Kenneth Gundle, MD|
|Sub-Investigator: Arthur Hung, MD|
|Cliniques Universitaires Saint-Luc||Recruiting|
|Contact: Zeyneb El Mouch +32 2 764 25 60 email@example.com|
|Principal Investigator: Thomas Schubert, MD, PhD|
|Sub-Investigator: Xavier Geets, MD, PhD|
|The Ottawa Hospital Cancer Centre||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Yusra Al Mosuli (613) 737-8920 firstname.lastname@example.org|
|Principal Investigator: Jean-Michel Caudrelier, MD|
|Sub-Investigator: Joel Werier, MD|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Contact: Anthony Griffin, MSc (416) 586-5975 email@example.com|
|Principal Investigator: Peter Ferguson, MD|
|Sub-Investigator: Jay Wunder, MD|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Colleen Dickie, MSc (416) 946-4501 ext 3467 firstname.lastname@example.org|
|Contact: Anthony M Griffin, MSc 14165865975 email@example.com|
|Principal Investigator: Peter Chung, MD|
|Sub-Investigator: Brian O'Sullivan, MD|
|Sub-Investigator: Charles Catton, MD|
|Sub-Investigator: David Shultz, MD|
|Montreal, Quebec, Canada, H1T 2M4|
|Contact: Hugo St.-Yves, MSc 1-514-252-3400 ext 4428 firstname.lastname@example.org|
|Contact: Janie Barry, MSc 1-514-252-3400 ext 4428 email@example.com|
|Principal Investigator: Nader Khaouam, MD|
|Sub-Investigator: Sophie Mottard, MD|
|Principal Investigator:||Peter Ferguson, MD, FRCSC||MOUNT SINAI HOSPITAL|
|Principal Investigator:||Peter Chung, MD||Princess Margaret Cancer Centre|
|Responsible Party:||Mount Sinai Hospital, Canada|
|Other Study ID Numbers:||
OCREB # 15-070
|First Posted:||October 1, 2015 Key Record Dates|
|Last Update Posted:||September 11, 2020|
|Last Verified:||September 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Soft tissue sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type