Status:
COMPLETED
NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity
Lead Sponsor:
Nanobiotix
Conditions:
Adult Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy...
Detailed Description
Patients will receive a single intratumor injection of NBTXR3 on day 1 and will receive external beam radiotherapy starting on day 2 up to completion of 5 weeks, 5 days a week of treatment (50Gy, 2Gy/...
Eligibility Criteria
Inclusion
- Age: 18 years and older
- Soft tissue sarcoma of the extremity or trunk wall, or localized in the posterior region of the neck (i.e., coronal section passing through the posterior limit of the ear)
- Locally advanced soft tissue sarcoma,candidate to radiotherapy
- Primary tumor or,
- Relapsed tumor, localized out of already irradiated area or,
- Sarcomas secondary to previous irradiation exposure due to other primary cancer
- WHO performance score 0 to 2
- Adequate function of Bone marrow:
- Adequate renal function
- Adequate liver function
- All female patients of childbearing potential must have a negative serum/urinary pregnancy test
Exclusion
- Written Informed Consent not obtained, signed and dated
- Patients with the following histological type: Gastrointestinal Stromal Tumors (GIST), embryonal or alveolar rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma or chondrosarcoma, Kaposi's sarcoma, primitive neuroectodermal tumor or dermatofibrosarcoma protuberans
- Soft tissue sarcoma of the trunk wall localized in the abdominal region, i.e. the region defined cranially by the xiphoid process of the sternum and the costal margins, and caudally by the line joining the anterior superior iliac spines, both limited by the perpendicular lines crossing both nipples
- Angiosarcoma of the trunk wall because of its diffuse frontier
- Metastatic disease (CT-scan verification) with survival expectation \< 6 months
- Concurrent treatment with any other anticancer therapy
- Absence of histologically or cytologically proven cancer at the first diagnosis
- Previous neoadjuvant chemotherapy treatment given as an upfront of the current treatment line
- Previous radiation therapy in relapse site of the soft tissue sarcoma (no radiation re-challenge is permitted)
- Moderate and severe liver dysfunction
- Hemolytic anemia
- Autoimmune disease
- Complete initial work up earlier than 4 weeks prior to patient registration
- Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Patients participating in another clinical investigation at the time of signature of the informed consent.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01433068
Start Date
October 1 2011
End Date
February 1 2015
Last Update
October 6 2020
Active Locations (2)
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1
Institut Bergonie
Bordeaux, France, 33076
2
Institut Gustave Roussy
Villejuif, France, 94805