Clinical trial · Interventional
Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities
Phase I Trial Study of Gemcitabine and Docetaxel With Radiation in Adult Patients With High Grade and Greater Than 5 cm Soft Tissue Sarcoma of the Extremities
NCT04037527CI-TRIAL-00116954terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due DLTs
Summary
Brief summary (as posted)
The purpose of this Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draws | Other | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Chemotherapy Plus Radiation Therapy
- description
- Up to 6 cycles (once a week) of chemotherapy with a 3+3 dose escalating plan (from 100 mg to 300 mg for Gemcitabine; 10 mg to 25 mg for Docetaxel) along with radiation (five days a week) for up to 6 weeks.
- interventionNames
- Drug: Gemcitabine
- Drug: Docetaxel
- Radiation: Radiation
- Procedure: Surgical Resection
- Other: Blood draws
Primary outcomes (2)
- measure
- Maximum Tolerated Dose Chemotherapy and Radiation
- timeFrame
- Up to 8 weeks
- description
- Maximum tolerated dose of Gemcitabine and Taxotere and radiation will be completed by monitoring toxicities and using the 3+3 dose escalation plan.
- measure
- Number of Toxicity Incidences
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a histologically or cytologically confirmed Grade II or III soft tissue sarcoma that is considered to be resectable and are candidates for pre-op radiation. * Age greater than or equal to 18 years. No children will be enrolled on this protocol. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives. * Patients taking an investigational agent are excluded. * Pregnant and nursing women are excluded. * Patients who require amputation for local control. * Patients who underwent unplanned excision or other previous surgery involving the affected extremity. * Patients with sarcoma subtypes for which established chemotherapeutic regimens exist. * History of radiation to the limb.
References
Publications (0)
Data not yet available
No reference posted for this study.