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Trial Title:
The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities
NCT ID:
NCT06593899
Condition:
Soft Tissue Sarcomas
Conditions: Official terms:
Sarcoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Hypofractionated Radiotherapy
Description:
Hypofractionated radiotherapy Preoperative hypofractionated 5x5 Gy radiotherapy (5
consecutive days) prescribed on planned target volume
Arm group label:
Hypofractionated Radiotherapy
Intervention type:
Drug
Intervention name:
3 cycles of AI
Description:
Three courses of doxorubicin and ifosfamide (AI, doxorubicin 75 mg/sqm and ifosfamide 10
g/sqm with prophylactic mesna)
Arm group label:
Hypofractionated Radiotherapy
Summary:
For localized soft tissue sarcomas (STS) of the extremities, limb-sparing or conservative
surgery with perioperative radiotherapy (RT) is the standard of care. However, several
challenges persist. Notably, there are exceedingly high rates of distant metastatic
recurrence even after surgical resection and RT, and conventional fractionated
radiotherapy has a prolonged duration (5-6 weeks). With advancements in RT technology,
the gradual expansion of hypofractionated radiotherapy regimens enables significantly
shorter treatment durations. Promising recent reports on 1-week hypofractionated RT
regimens, such as the 5X5 Gy RT regimens, have demonstrated reasonable local control and
acceptable toxicity in resectable STS.Addressing the challenge of distant metastasis,
previous studies have indicated that AI regimens are expected to eliminate
micrometastases and improve survival in patients with STS at a high risk of distant
relapse. Therefore, the goal of this clinical trial is to investigate whether
hypofractionated RT combined with a sequential chemotherapy（AI regimens）can enhance
short-term treatment efficacy for extremity STS patients without compromising local
control rates and increasing related toxicities
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Primary soft tissue sarcoma of the extremities, with one of the following
characteristics: high grade, ≥5cm or deep tumor, the need for neoadjuvant
radiotherapy was determined after multidisciplinary consultation.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
3. Age 18-75 years old.
4. Histologic diagnosis of soft tissue sarcoma.
5. Can tolerate radiotherapy and AI regimen treatment.
6. The function of major organs is normal.
Exclusion Criteria:
1. There were no patients with gross tumors after unplanned mass resection in another
hospital.
2. Patients with other comorbidities cannot use AI chemotherapy: drug allergy, active
bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrollable
hypertension, grade III-IV cardiac insufficiency (NYHA standards), severe liver and
renal insufficiency ( Level IV) etc.
3. New malignant tumors within 5 years (except cervical carcinoma in situ or early
cutaneous basal cell carcinoma).
4. Pathological types: nonpleomorphic rhabdomyosarcoma, Ewing sarcoma.
5. Soft tissue sarcoma curable by simple expansion.
6. Previous history of radiotherapy to the same site.
7. Combined with distant metastasis (M1) or lymph node metastasis (N1).
8. Have other severe medical comorbidities that preclude surgery or participation in
the study.
9. Previous exposure to chemotherapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Yang, Doctor
Phone:
18813019084
Email:
dr_yangyong1983@163.com
Start date:
May 1, 2024
Completion date:
July 1, 2026
Lead sponsor:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Source:
Fujian Medical University Union Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06593899
