Clinical trial · Interventional
A Study on the Safety and Effectiveness of Temozolomide for Neoadjuvant Treatment of PPGL
A Study on the Safety and Effectiveness of Temozolomide for Neoadjuvant Treatment of Pheochromocytoma or Paraganglioma Patients
NCT05885386CI-TRIAL-00066860unknownPhase 2ClinicalTrials.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)
This phase II trial studies the effectiveness oftemozolomide in the neoadjuvant therapy oflocally advanced,or unresectable pheochromocytoma or paragangliom(PPGL). Temozolomide (TMZ) is a novel oral alkylation chemotherapeutic agent. Inthisstudy,temozolomidewill be used preoperatively in order to change unresectable tumors to resectable and reduce the high risk of surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Paraganglioma | Paraganglioma | ONTOLOGY_EXACT | 0.98 |
| Pheochromocytoma | Adrenal Gland Pheochromocytoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Pheochromocytoma or Paraganglioma patients
- description
- TMZ was administered orally at an initial daily dose of 150 mg/m2 per day for 5 days, every 28 days preoperatively. In patients with a good tolerance during the first cycle, the dose was increased to 200 mg/m2 per day for 5 days, every 28 days.
- interventionNames
- Drug: Temozolomide
Primary outcomes (1)
- measure
- The proportion of patients whose tumor change from unresectable to resectable tumor
- timeFrame
- At the end of Cycle 3 (each cycle is 28 days)
- description
- The proportion of PPGL patients whose tumor change from unresectable to resectable
Secondary outcomes (7)
- measure
- the objective response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Provide written informed consent. * Age 10-70 years old * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. * The patient is diagnosed as pheochromocytoma or paraganglioma which is unresectable with R0 surgery, or extensive and thus maybe requiring resection of important organs, or Inoperable due to heart and other complications, or with very high surgical risk. * Estimated life expectancy longer than 6 months. * Confirmed non-pregnancy and lactation. During the entire study period and within 6 months after the last administration, the subjects and their spouses are willing to use efficient contraceptive measures. * Laboratory requirements: * Absolute granulocyte count (AGC) greater than 1.5 x 109/L; * Platelet count greater than 80 x 109/L; 3) Hemoglobin greater than 90g/L; * Serum bilirubin less than 1.5 x upper limit of normal (ULN); * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN; Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min; * Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%). Exclusion Criteria: * Have other tumors. * Patients were treated with other antitumor agents. * Pregnant or nursing women. * A history of allergic reactions to temozolomide or dacarbazine. * Severe myelosuppression or abnormal coagulation. * Severe liver and kidney insufficiency. * Bowel obstruction or other conditions that interfere with taking medication.
References
Publications (0)
Data not yet available
No reference posted for this study.