Clinical trial · Interventional
Effectiveness of the Combined WLI and Hyperthermia for GI Cancer Liver Metastasis
Effectiveness of the Combined Whole Liver Irradiation (WLI) and Hyperthermia for Unresectable Chemoresistant Multiple Liver Metastasis From Gastrointestinal Tract Cancer: Prospective Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is chemotherapy, but considerable portion of the patients progressed and most of the liver is converted to metastatic tumor lesions. Significant quality of life decrement was detected in those patients, especially in patients suffered severe symptoms Several studies reported that whole liver RT (WLRT) can be used effectively to control severe symptoms from unresectable liver metastasis in gastrointestinal tract cancer patients. However, it is well known fact that the liver is a very sensitive to RT. Despite symptom palliation is obtained after 20 to 30 Gy RT but only in small subset of patients get local control. In this aspect, the combined with radiosensitizer with WLRT is considered to enhance RT effect to palliate symptom and control local tumor progression, and increase the quality of life ultimately. It is reported that hyperthermia is considered as the most valuable radiosensitizer in cancer treatment, theoretically. Based on those studies, we start this prospective study to investigate the effect of combination treatment of WLRT and hyperthermia on quality of life in the patients with unresectable chemoresistant liver metastasis from gastrointestinal tract cancer.
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 |
|---|---|---|---|
| Hyperthermia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined hyperthermia and radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined hypertermia and RT
- description
- Combined hypertermia and radiothearpy
- interventionNames
- Radiation: Combined hyperthermia and radiation therapy
Primary outcomes (1)
- measure
- Time to Local Tumor Progression After Combined Hyperthermia and RT
- timeFrame
- Patient will be evaluated after combined hyperthermia and RT until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 19 months.
- description
- Local progression will be defined as more than 20% size increase of metastatic lesions or new metastatic lesion in liver. Time to local tumor progression will be measured from the date of RT start to the date of local progression or last follow-up visit.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 1 Patients must have a diagnosis of pathologic proven gastrointestinal tract cancer * 2 Unresectable and unsuitable to other local modalities * 3 Not responded and/or unsuitable to chemotherapy * 4 Eastern Cooperative Oncology Group ECOG) performance status 0 to 3 * 5 Assessment by colorectal tumor board (surgeon, radiation oncologist and medical oncologist participated) * 6 Age ≥ 20 * 7 Agreement of study-specific informed consent * 8 Blood work requirements * Absolute neutrophil count (ANC) ≥ 1,500 /mm3, Platelet ≥ 50,000/mm3, Hgb ≥ 8 g/dl * Liver function test(LFT): Total bilirubin\<3.0 mg/dL, International normalized ratio(INR) \< 1.7, Albumin ≥ 2.8g/dL, Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT)\< 6 X normal * Serum creatinine \< 1.5 X normal, or Creatinine clearance rate (CCr) ≥ 60 mL/min * 9 Child-Pugh score 10 or less within 1 week before WLI * 10 Childbearing potential woman, consent contraception at least 6 months * 11 Stable breathing more than 5 minutes Exclusion Criteria: * 1 Life expectancy less than 8 weeks * 2 Pregnant and/or breastfeeding woman * 3 Previous upper abdominal RT history * 4 Uncontrolled ascites or hepatic encephalopathy * 5 Unstable respiration due to pleural effusion, chronic obstructive pulmonary disease COPD) etc
References
Publications (0)
Data not yet available