search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Voorbehandeling met chemotherapie, verwarmde buikspoeling met chemotherapie na chirugische verwijdering van alle tumor bij patienten met buikvlies uizaaiingen van dikke darm of endeldarm kanker.


- candidate number14520
- NTR NumberNTR3905
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-mrt-2013
- Secondary IDsNL34659.042.11 CCMO
- Public TitleVoorbehandeling met chemotherapie, verwarmde buikspoeling met chemotherapie na chirugische verwijdering van alle tumor bij patienten met buikvlies uizaaiingen van dikke darm of endeldarm kanker.
- Scientific TitleNeo-adjuvant chemotherapy, cytoreductive surgery with hyperthermic intra-peritoneal chemotherapy for peritoneal carcinomatosis of colorectal origin (NACHO-trial).
- ACRONYMNACHO-trial
- hypothesisNeo-adjuvant chemotherapy facilitates complete cytoreduction without negative effects on safety.Therby offering a possibility of better overall survival.
- Healt Condition(s) or Problem(s) studiedSurgery, Neoadjuvant chemotherapy, Cytoreduction, HIPEC, Peritoneal metastasis
- Inclusion criteria1. Peritoneal carcinomatosis of colorectal origin diagnosed either at laparotomy or by malignant ascites on CT-scan. When ascites is diagnosed, cytologic confirmation of peritoneal carcinomatosis is sufficient. At laparotomy either histologic or cytologic confirmation of peritoneal carcinomatosis is sufficient;
2. Age of 18 years of older;
3. WHO performance score of 0, 1 or 2;
4. Adequate bone marrow function, defined as platelets > 100 x 109 /l and neutrophils > 1.5 x 109 /l;
5. Adequate renal function, defined as creatinine clearance of > 50 ml/min measured using the Cockroft Gault formula;
6. Informed consent provided.
- Exclusion criteria1. Previous chemotherapy except adjuvant chemotherapy with an interval between the end of adjuvant chemotherapy and the start of neo-adjuvant chemotherapy of at least 12 months;
2. History of other malignancy, exept basal cell carcinoma;
3. Advanced liver disease, defined as bilirubin >34 umol/l and/or PT > 1,7(INR);
4. Liver and/or extra abdominal metastases;
5. Neurotoxicity > grade 1 according CTC AE 4.0.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 22-mrt-2013
- planned closingdate30-jun-2015
- Target number of participants50
- InterventionsNeo-adjuvant chemotherapy giving six cycles of oxaliplatin and capecitbine preoperatively followed by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy using mitomycin C.
- Primary outcomeEfficacy of neo-adjuvant chemotherapy with respect to the percentage of patients who are resectable after neo-adjuvant chemotherapy.
- Secondary outcome1. The response of peritoneal carcinomatosis to chemotherapy according to RECIST criteria and postoperative pathological examination;
2. Safety of neo-adjuvant chemotherapy and CRS+HIPEC with respect to 30-day or in-hospital mortality;
3. Quality of life as measured by the EORTC-QLQ C30 quality of life questionnaire;
4. Morbidity of surgery according to the NCI-CTC v4.0;
5. The effect of chemotherapy and CRS with HIPEC on intestinal barrier function as measured by IFAB levels;
6. The percentage of patients able to complete full treatment.
- TimepointsDirectly postoperative, 30 days postoperative, 3 months, 6 months, 1 year.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P.H.J. Hemmer
- CONTACT for SCIENTIFIC QUERIES P.H.J. Hemmer
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryComplete surgical removal of tumor (cytoreduction) with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic chemotherapy, has been found to be a potentially curative treatment in peritoneal carcinomatosis of colorectal origin. Treatment schedules not involving cytoreductive surgery and hyperthermic intraperitoneal chemotherapy offer no curation and prolong median survival with 2 years. Surgical treatment without systemic chemotherapy does not prevent lymphogenic and haematogenous spread of the disease as the HIPEC is only directed against intra-abdominal tumor cells. To prevent and/or treat lymphogenic spread systemic treatment is provided. However, after HIPEC treatment many patients are not able to complete their systemic treatment due to the short term postoperative morbidity of the HIPEC. Neo-adjuvant systemic chemotherapy is expected to reduce tumor volume thus facilitating radical cytoreduction and will possibly offer long term curation in more patients. Also by giving the systemic treatment preoperatively, more patients will be able to complete treatment and may as a result have an additional survival benefit. The feasibility of neo-adjuvant chemotherapy added to cytoreductive surgery with hyperthermic intra-peritoneal chemotherapy will be investigated. Also the efficacy of neo-adjuvant chemotherapy with regard to the number of patients in whom a complete cytoreductive surgery can be performed, will be studied.
- Main changes (audit trail)
- RECORD20-mrt-2013 - 1-apr-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl