Clinical trial · Interventional
PP-Gemcitabine & External Beam Radiation-Sarcomas
A Phase I Study of Preoperative Concomitant Gemcitabine and External-Beam Radiation Therapy and Surgical Resection for Patients With Extremity and Trunk Soft Tissue Sarcomas
NCT02046304CI-TRIAL-00021645completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.
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 |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Radiation Therapy
- description
- Patients receive concurrent chemoradiation (days 1 - 33) consisting of external beam radiotherapy (EBRT) plus gemcitabine, administered in a phase I dose escalation format until MTD is reached. EBRT delivered preoperatively (for patients with measurable disease) or postoperatively (for patients who have undergone pre-referral excisional biopsy) to a dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks. Surgical resection of the post-treatment tumor mass performed 4 to 8 weeks after the final dose of gemcitabine. Gemcitabine administered intravenously (IV) on days 1, 8, 22, 29, 43, and 50, concurrently with radiotherapy. Starting dose of gemcitabine 400 mg/m2 by vein once a week.
- interventionNames
- Drug: Gemcitabine
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Maximum Tolerated Dose of Preoperative Gemcitabine with External-Beam Radiation Therapy
- timeFrame
- 6 weeks
- description
- The maximum tolerated dose (MTD) defined as the dose having posterior expected toxicity importance score (TIS) closest to the target 1.65 at the end of the trial.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with cytologic or histologic proof of Grade II or III resectable soft tissue sarcoma of the extremity or trunk. 2. Patients with both measurable and non-measurable disease. Patients who are S/P pre-referral excision will be eligible. 3. Inclusion of patients with a prior history of malignancy will be at the discretion of the Study Chairman. 4. Patients must have a Zubrod Point Scale of 0 or 1. 5. Absolute neutrophil count must be \> 1,500 cells/mm; platelet count greater than or equal to 100,000 platelets/ml; serum creatinine less than or equal to 1.8 mg/dl, serum glutamate oxaloacetate transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) less than or equal to 3 x normal, total bilirubin less then or equal to 1.5 mg/dl. 6. Patients must have no uncontrolled coexisting medical conditions. 7. Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception. 8. All patients must sign an informed consent. Exclusion Criteria: 1\) Patients with a history of prior radiotherapy in the area of the primary tumor or those in whom the anticipated radiation field would include the perineum, scrotum, or vaginal introitus will not be eligible.
References
Publications (0)
Data not yet available
No reference posted for this study.