* The primary objective of this study is:- the study of the response rate and the macroscopic and microscopic response charactheristics of neo-adjuvant chemotherapy of patients with peritoneal carcinomatosis (PC) of colorectal origin. * Secundary…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* The primary objective of this study is:
- the study of the response rate and the macroscopic and microscopic response
charactheristics of neo-adjuvant chemotherapy of patients with peritoneal
carcinomatosis (PC) of colorectal origin.
Secondary outcome
* Secundary objectives of this study are:
- assessment of the toxicity of this neo-adjuvant chemotherapy combination.
- assessmet of the drop-out percentage after surgical exploration, the extent
of the PC after this neo-adjuvante therapy still exceeds 5 abdominal regions.
- assessment of the toxicity of complete cytoreductive surgery and HIPEC after
neo-adjuvante treatment in PC of colorectal origin.
Background summary
* Titel:
*A pilot study evaluating response to induction chemotherapy with oxaliplatin,
capecitabine and bevacizumab in patients with extensive peritoneal
carcinomatosis of colorectal origin.*
* Fase:
A phase II pilot study
* Ontwerp:
An open label, non-randomized, uncontrolled, single group assignment, pilot
efficacy study.
Study objective
* The primary objective of this study is:
- the study of the response rate and the macroscopic and microscopic response
charactheristics of neo-adjuvant chemotherapy of patients with peritoneal
carcinomatosis (PC) of colorectal origin.
* Secundary objectives of this study are:
- assessment of the toxicity of this neo-adjuvant chemotherapy combination.
- assessmet of the drop-out percentage after surgical exploration, the extent
of the PC after this neo-adjuvante therapy still exceeds 5 abdominal regions.
- assessment of the toxicity of complete cytoreductive surgery and HIPEC after
neo-adjuvante treatment in PC of colorectal origin.
Study design
* Design:
An open label, non-randomized, uncontrolled, single group assignment, pilot
efficacy study.
* Patients:
About forty-seven (47) patients with initially inoperable peritoneal
carcinomatosis of colorectal origin wil undergo neo-adjuvant chemotherapy with
oxaliplatin, capecitabine en bevacizumab and subsequently a new investigation
will be performed to assess the response rate, possible downstaging under this
neo-adjuvant treatment and the macroscopic and microscopic response
charactheristics of neo-adjuvant chemotherapy of patients with peritoneal
carcinomatosis (PC) of colorectal origin. .
Intervention
1 additional laparoscopy
Study burden and risks
very limited, because only once additional performance of lab, PET/CT and
laparoscopy with biopsy, when compared to the normal therapy course of a
patient with peritoneal carcinomatosis of colorectal cancer.
Plesmanlaan 121
1066CX Amsterdam
NL
Plesmanlaan 121
1066CX Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* Primary tumor: histologically proven adenocarcinoma in appendix, colon or rectum, that can be seen as the primary tumor related to the peritoneale carcinomatosis, and that is still present at inclusion or has been previously resected.
* Intraperitoneal disease: inoperable peritoneal carcinomatosis (i.e. peritoneal carcinomatosis in more than 5 of 7 abdominal regions) of colorectal origin, histologically proven.
* patients:
- 18 years or older.
- WHO performance status 0 or 1.
- fit to undergo major surgery as well as chemotherapy.
- life expectancy > 4 months without therapy.
- written informed consent, obtained before inclusion in the study.
- normal bone marrow reserve (i.e. leucocytes > 2000/l and
thrombocytes > 80,000/l) .
- bilirubine < 2.5 times the normal upper limit.
- ASAT and ALAT < 2.5 times the normal upper limit.
- normal creatinine-level and a negative dipstick-test for protein
of < 1 gram protein in a 24-hour urine collection.
Exclusion criteria
- Symptoms of bowel obstruction (in case of symptoms of bowel obstruction bypass-surgery or construction of an ostomy is necessary before inclusion into the study).
- Extra-peritoneal, systemic disease on CT thorax/abdomen. Liver metastases are considered systemic disease, as well as bone metastases.
- Bleeding diathesis of coagulopathy.
- Medical history of CVA or TIA, uncontrolled hypertension, instable angina pectoris, myocardial infarction within 6 months before inclusion, congestif heart failure NYHA class II or higher, arhythmia.
- Instable or uncompensated respiratory disease.
- Neuropathy in the medical history.
- Pregnancy or lactation. Fertile patients who do not use contraceptive drugs.
- Previous or concomitant malignancies in the past 5 years, other then non-melanoma skin cancer or carcinoma in situ.
- Active infection.
- Chemotherapy with oxaliplatin or fluorouracil within 1 year before inclusion, progressive disease under oxaliplatin or fluorouracil at any time before inclusion, any major toxicity in the past, originating from any drugs used in this protocol.
- Short bowel syndrome.
- Surgery within 3 maanden before inclusion, leading to an abdominal sepsis or fistulisation (in case of fistulisation patients must have a stable situation of at least 3 months, without signs of active infection or abscess).
- Previous complete cytoreductive surgery (CCRS) and HIPEC and/or surgery leading to an anatomical situation in which CCRS en HIPEC have become impossible.
- Current therapy with and other investigational agent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-017776-24-NL |
| CCMO | NL30577.031.09 |