Clinical trial · Interventional
Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix Cancer
Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer
- 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)
RATIONALE: Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving thalidomide after surgery and chemotherapy may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well thalidomide works in treating patients who have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or appendix cancer .
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 |
|---|---|---|---|
| Carcinoma of the Appendix | Appendix Carcinoma | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| surgery | Procedure | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemo therapy followed by thalidomide
- description
- After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
- interventionNames
- Drug: thalidomide
- Procedure: surgery
Primary outcomes (1)
- measure
- Time to Progression
- timeFrame
- 9 hours
- description
- Time to progression after surgery was recorded.
Secondary outcomes (2)
- measure
- Progression Free Survival
- timeFrame
- 60 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Pathologically confirmed peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer
* Underwent cytoreductive surgery and intraperitoneal hyperthermic chemotherapy (IPHC) within the past 12 weeks
* Patients with residual disease or no evidence of disease after IPHC are eligible
* No extra-abdominal disease or parenchymal liver metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Free of infection or postoperative complications
* Hemoglobin \> 8.0 g/dL
* Absolute neutrophil count \> 1,000/mm³
* Platelet count \> 100,000/mm³
* PTT or PT \< 1.5 times normal (except in patients who are receiving therapeutic anticoagulant therapy for non-related medical conditions, such as atrial fibrillation)
* Bilirubin \< 1.5 mg/dL OR direct bilirubin ≤ 1.0 mg/dL (for patients with Gilbert's syndrome)
* AST/ALT ≤ 2.5 times normal
* Serum creatinine \< 2.0 mg/dL
* No peripheral neuropathy \> grade 1, except localized neuropathy due to a mechanical cause or trauma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception for 4 months prior to, during, and for 4 months after treatment with thalidomide
* No history of hepatic cirrhosis
* No history of severe hypothyroidism
* No history of medical problem such as severe congestive heart failure or active ischemic heart disease
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No known history of deep vein thrombosis or pulmonary embolus
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior chemotherapy, biologic therapy, or radiotherapy (except for IPHC)
* No other concurrent systemic therapy
* No concurrent high level sedatives
* No concurrent sedating "recreational" drugs or alcoholReferences
Publications (0)
Data not yet available