Pseudomyxoma Peritonei Clinical Trial
— ACAPPOfficial title:
Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients Treated With CYTOREDUCTIVE SURGERY (CRS) and HYPERTERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC)
This is a phase II, mono institutional, non comparative study, evaluating adjuvant capecitabine in patients affected by KRAS mutated Pseudomyxoma peritonei treated with cytoreductive surgery and HIPEC. Patient will be treated with 8 cycles of the study regimen that include: Capecitabine 1250 mg/m2 PO BID day 1-14 q21 days
Status | Recruiting |
Enrollment | 28 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 76 Years |
Eligibility | Inclusion Criteria: - Patients submitted to a complete cytoreductive surgery and subsequent HIPEC for PMP - Histological diagnosis of pseudomyxoma peritonei (PMP) - Assessment of KRAS mutation positivity on surgical sample - Age >= 18 years and <76 years - Performance Status (ECOG <2) - Adequate organ function including the following: - Adequate bone marrow reserve: WBC count >3.0x109/L, absolute neutrophyl count >1.5x109/L, platelet count >100x109/L, and hemoglobin >10 g/dL - Hepatic: bilirubin < 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 xULN - Renal: Creatinine clearance >50 mL/min or serum creatinine 1.5 x UNL - Patients compliance and geographic proximity that allows for adequate follow-up - Patients must sign an informed consent document (ICD) - Male and female patients with reproductive potential must use an approved contraceptive method. Exclusion Criteria: - Previous systemic chemotherapy and/or biological therapy - Administration of other experimental drugs during the study - Pregnancy and breast-feeding - Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment - Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis - Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures. - Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano | Milano | MI |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS | To evaluate the efficacy of postoperative capecitabine in terms of progression free survival (PFS) after CRS and HIPEC in patients with KRAS mutated PMP with extensive peritoneal disease | Progression free survival is time between treatment start date and first date of recurrence or death, whichever occurs first. | |
Secondary | OS | To assess the efficacy of adjuvant capecitabine treatment in terms of overall survival (OS) | Overall survival (OS) is time between the date of chemotherapy start and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive | |
Secondary | DSS | To assess the efficacy of adjuvant capecitabine treatment in terms of isease specific survival (DSS) | Disease Specific Survival (DSS) is time between the date of chemotherapy start and the date of death caused by cancer. Deaths from other causes are not "events". |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04024917 -
Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
|
N/A | |
Completed |
NCT02374411 -
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
|
N/A | |
Recruiting |
NCT02073500 -
Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
|
||
Active, not recruiting |
NCT01427101 -
Results of CRS and Debulking in PMP Patients
|
N/A | |
Active, not recruiting |
NCT04982146 -
Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei
|
Phase 1 | |
Completed |
NCT04088786 -
Phase I Trial HIPEC With Nal-irinotecan
|
Phase 1 | |
Not yet recruiting |
NCT06084780 -
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
|
Phase 2 | |
Active, not recruiting |
NCT02834169 -
French National Registry of Rare Peritoneal Surface Malignancies
|
N/A | |
Completed |
NCT01764789 -
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
|
N/A | |
Completed |
NCT02040142 -
Single Arm Study Treating Patients of Peritoneal Surface Malignancy (Colorectal, Appendical, Pseudomyxoma, Gastric) With Cytoreductive Surgery and Hyperthermic Intraperitoneal Mitomycin-C
|
Phase 2 | |
Withdrawn |
NCT04125225 -
What Are the Experiences of Patients With Pseudomyxoma Peritonei?
|
||
Not yet recruiting |
NCT03976973 -
BromAc for Recurrent Peritoneal Mucinous Tumour or Pseudomyxoma Peritonei
|
Phase 2 | |
Recruiting |
NCT01617382 -
Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed
|
||
Completed |
NCT01652794 -
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
|
Phase 1 | |
Completed |
NCT01126346 -
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
|
N/A | |
Completed |
NCT05513183 -
Severe Neutropenia After HIPEC Using Mitomycin-C
|
||
Active, not recruiting |
NCT02834013 -
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
|
Phase 2 | |
Recruiting |
NCT03210298 -
International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)
|
||
Active, not recruiting |
NCT02387203 -
Antibiotic Treatment and Long-term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin
|
Phase 2 | |
Terminated |
NCT04665921 -
A Study of SGN-STNV in Advanced Solid Tumors
|
Phase 1 |