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The purpose of this study is to evaluate whether a second-look laparoscopy, followed by peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in case of peritoneal carcinosis, improves the overall survival of patients who have had radical resection of mucinous colorectal cancer.
Patients will be entered into the study after radical resection of mucinous colorectal cancer, and reevaluated by CT scan after 6 months. Patients with no evidence of disease will be randomized to receive either standard follow up, or to have a second look laparoscopy to evaluate for peritoneal carcinosis. After laparoscopy, those patients who do not have peritoneal carcinosis will continue with standard follow up. Patients with peritoneal carcinosis diagnosed by laparoscopy will be treated according to their peritoneal carcinosis index (PCI). For patients with PCI > 20, systemic chemotherapy will be given according to Italian Association of Medical Oncology (AIOM) guidelines. Patients with PCI < 20 will undergo peritonectomy and then receive intravenous chemotherapy immediately followed by HIPEC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Second look laparoscopy | Experimental | Second look laparoscopy to evaluate for and treat peritoneal carcinosis |
|
| standard follow up | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopy | Procedure | second look laparoscopy to evaluate for peritoneal carcinosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | two years |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm | 6 months | |
| changes in quality of life | quality of life is measured at baseline and 6 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Perrone, M.D., Ph.D. | Contact | +39 081 5903571 | francesco.perrone@usc-intnapoli.net | |
| Marilina Piccirillo, M.D. | Contact | +39 081 5903383 | marilina.piccirillo@usc-intnapoli.net |
| Name | Affiliation | Role |
|---|---|---|
| C. Sassaroli, M.D. | National Cancer Institute, Naples | Principal Investigator |
| A Cassata, M.D. | University of Campania Luigi Vanvitelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico | Recruiting | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| peritonectomy | Procedure | for patients with PCI < 20 |
|
| Folinic Acid | Drug | 20 mg/m2 IV given just before HIPEC for patients with PCI < 20 |
|
| 5-Fluorouracil | Drug | 400 mg/m2 IV given just before HIPEC in patients with PCI < 20 |
|
| Oxaliplatin | Drug | 460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI < 20 |
|
| systemic chemotherapy | Drug | according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI > 20 |
|
| 6 months |
| overall survival | five years |
| worst grade adverse event per patient | toxicity measured only in experimental arm, weekly from randomization to 30 days after experimental treatment | 7 months |
| number of patients with radiologic evidence of disease after initial surgery | 6 months |
| list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery | description of therapies and outcomes for those patients who were not randomized due to presence of disease | two years |
| M.C. Piccirillo, M.D. |
| NCI Naples |
| Principal Investigator |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |