Clinical trial · Interventional
Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy
Treatment of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy A Phase II Randomized Trial
NCT00765570CI-TRIAL-00017938terminatedPhase 2Results postedClinicalTrials.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): Accrual too slow - would not enroll enough subjects to determine outcome
Summary
Brief summary (as posted)
Expand clinical literature on the use of Grid radiation with conventional external beam therapy. Vast majority of therapy is for palliative care to provide relief from pain, but has also shown a reduction in the size of tumor mass.
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 |
|---|---|---|---|
| Advanced Bulky Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spatially Fractioned Radiation Therapy | Radiation | — | UNRESOLVED |
| Standard radiation | Radiation | — | UNRESOLVED |
| Treatment Group 1 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment Group 1
- description
- Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
- interventionNames
- Radiation: Spatially Fractioned Radiation Therapy
- Radiation: Treatment Group 1
- type
- ACTIVE_COMPARATOR
- label
- Treatment Group-2
- description
- Treatment Group 2-15 treatments with standard radiation
- interventionNames
- Radiation: Standard radiation
Primary outcomes (1)
- measure
- Protocol Treatment Related Morbidity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologic or cytologic diagnosis of primary or metastatic epithelial cancer or sarcoma located in the head and neck area, lung, abdomen or pelvis. * Tumors must have an overall dimension greater than 24 cm2 (bidimensional) with one dimensions \>6 cm, by x-ray, CT/MRI scan or clinical exam. * Age \>18 * Karnofsky \> 70 with life expectancy \>3 months. * Patients may not begin new hormone therapy within 2 weeks of initiation of protocol treatment. * No planned initiation of hormone therapy within 2 weeks of protocol therapy * Adequate bone marrow function: Hb \> 9, white blood cell count (WBC) \> 2,000. Hepatic function \< 3x upper limit of laboratory normal values. * Laboratory studies will be obtained within 2 weeks prior to randomization. * Patients with metastatic sites of disease including brain are eligible provided that life expectancy is \> 3 months. Exclusion Criteria: * Hematologic-related tumors. * Tumors overlying critical central nervous system structures including spinal cord, eye or brainstem or require treatment portals over these vital structures. * Central nervous system tumors * Evidence of other primary malignancy except for carcinoma in situ of cervix or skin cancer excluding melanoma unless disease free for 2 years prior to randomization * Patients with spinal cord compression. * Prior radiation to treatment field. * Concomitant chemotherapy or chemotherapy within past 2 weeks. Planned initiation of chemotherapy within 2 weeks of completing protocol treatment
References
Publications (0)
Data not yet available
No reference posted for this study.