Clinical trial · Interventional
Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity
Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies
NCT01163552CI-TRIAL-00014838completedPhase 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)
Cancers that have spread to the inner lining of the chest are classified as Stage IV and bear a poor prognosis. Surgery is rarely an option, with palliative chemotherapy and/or radiation therapy the only treatment options. This study intends to evaluate whether surgical removal of all visible tumor on the chest wall followed by bathing the chest cavity in heated chemotherapy solution will improve outcomes for these advanced cancers.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pleural Metastases | — | UNRESOLVED | — |
| Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Thymic Cancer | — | UNRESOLVED | — |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical debulking and Intrathoracic Hyperthermic Chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy
- description
- Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion.
- interventionNames
- Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy
Primary outcomes (2)
- measure
- Time to disease progression
- timeFrame
- 1 year
- description
- Most cancers that have spread to the chest cavity have limited survival. Response to systemic chemotherapy and radiation therapy is short-lived. This end point will determine the time to disease progression of this experimental treatment modality.
- measure
- Survival
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults aged 18-75 years 2. Radiographic evidence of pleural dissemination with histologically or cytologically confirmed diagnosis. 3. Primary source control (breast, ovarian, uterine, colon, renal cell, thymic cancer) 4. Adequate liver and renal function defined as a bilirubin of \< 2.0 mg/dl, albumin \> 3.0g/dl, and a creatinine of \< 1.5 mg/dl, respectively. 5. Absolute neutrophil count (ANC) of ≥1,500/mm3 and a platelet count ≥100,000/mm3. 6. A Karnofsky Performance Status score of ≥60 Exclusion Criteria: 1. Patients without satisfactory oncological control of their primary cancer. 2. Radiographic evidence of abdominal, pelvic, or intracranial metastatic disease. 3. Chemotherapy and/or radiotherapy must have been completed at least one month prior to entry in the study. Patients may not receive concurrent chemotherapy, immunotherapy, radiotherapy, or any investigational drugs while participating in this study. 4. Significant active medical disease including, but not limited to: * Cardiac disease, including: congestive heart failure or angina pectoris; recent (within 1 year) history of a myocardial infarction; uncontrolled hypertension; arrhythmias. * Active infections * Uncontrolled diabetes mellitus * Chronic renal insufficiency * HIV/AIDS - routine HIV testing will not be performed, but patients known to be HIV positive will be excluded. 5. Pregnant or lactating women. 6. Allergy to intravenous contrast
References
Publications (5)
- BACKGROUNDMatsuzaki Y, Shibata K, Yoshioka M, Inoue M, Sekiya R, Onitsuka T, Iwamoto I, Koga Y. Intrapleural perfusion hyperthermo-chemotherapy for malignant pleural dissemination and effusion. Ann Thorac Surg. 1995 Jan;59(1):127-31. doi: 10.1016/0003-4975(94)00614-D. PMID 7818311
- BACKGROUNDRatto GB, Civalleri D, Esposito M, Spessa E, Alloisio A, De Cian F, Vannozzi MO. Pleural space perfusion with cisplatin in the multimodality treatment of malignant mesothelioma: a feasibility and pharmacokinetic study. J Thorac Cardiovasc Surg. 1999 Apr;117(4):759-65. doi: 10.1016/S0022-5223(99)70297-7. PMID 10096972
- BACKGROUNDYellin A, Simansky DA, Paley M, Refaely Y. Hyperthermic pleural perfusion with cisplatin: early clinical experience. Cancer. 2001 Oct 15;92(8):2197-203. doi: 10.1002/1097-0142(20011015)92:83.0.co;2-f. PMID 11596038
- BACKGROUNDIyoda A, Yusa T, Hiroshima K, Fujisawa T. Surgical resection combined with intrathoracic hyperthermic perfusion for thymic carcinoma with an intrathoracic disseminated lesion: a case report. Anticancer Res. 1999 Jan-Feb;19(1B):699-702. PMID 10216479
- BACKGROUNDRefaely Y, Simansky DA, Paley M, Gottfried M, Yellin A. Resection and perfusion thermochemotherapy: a new approach for the treatment of thymic malignancies with pleural spread. Ann Thorac Surg. 2001 Aug;72(2):366-70. doi: 10.1016/s0003-4975(01)02786-2. PMID 11515868