Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052962
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2003-01-26
Brief Title:
Debulking and Chemotherapy With or Without Intraperitoneal Chemotherapy to Treat Peritoneal Carcinomatosis
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Prospective Random Assignment Trial to Study Operative Debulking and Systemic Chemotherapy With or Without Intra-and Peri-Operative Intraperitoneal Chemotherapy for Subjects With Peritoneal Carcinomatosis From Low Grade Gastrointestinal Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine which of the two following treatment regimens provides greater benefit to patients with peritoneal carcinomatosis gastrointestinal cancer that has spread throughout the abdomen
Surgical removal of tumors plus heated chemotherapy during surgery followed by one dose of chemotherapy 7 to 12 days after surgery followed 3 weeks later by 4 months of chemotherapy or
Surgical removal of tumors followed by 4 months of chemotherapy starting 1 month after surgery
Patients 18 years of age and older with peritoneal carcinomatosis may be eligible for this study Candidates are screened with a medical history physical examination and blood tests chest X-ray and computed tomography CT scans review of pathology slides electrocardiogram EKG bone scan and brain magnetic resonance imaging MRI as needed and laparotomy Laparatomy is a surgical procedure in which an incision is made in the abdomen to look at the amount and location of tumors in the abdominal cavity Patients whose surgery reveals that the tumors cannot be removed are taken off study Those eligible for the study have their tumors removed during this screening laparotomy as part of the study procedure as follows
All participants undergo laparotomy and removal of as much tumor as possible as described above Patients are then randomly assigned to one of two treatment groups
Group 1 - During laparotomy after tumor removal patients receive continuous hyperthermic peritoneal perfusion CHPP with the anti-cancer drug cisplatin For CHPP the cisplatin solution is heated and delivered to the abdomen through a catheter plastic tube washed through the abdomen for 90 minutes and then drained out of the body through another catheter At the close of surgery a small catheter called a Tenckhoff catheter is left in the abdomen and brought out through the skin Between days 7 and 12 after surgery one dose of fluorouracil and paclitaxel chemotherapy is delivered through this catheter The catheter is removed following complete recovery from surgery and the patient is discharged from the hospital Four to 6 weeks after the surgery patients have CT scans of the chest pelvis and abdomen and then begin intravenous IV through a vein chemotherapy with oxaliplatin 5-fluorouracil 5-FU and leucovorin The chemotherapy is given in 4-week courses as follows oxaliplatin on day 1 infused over 2 hours through a vein in the arm or neck leucovorin on days 1 and 2 infused over 2 hours followed by 5-fluorouracil over 22 hours leucovorin and 5-FU repeated two weeks later on days 15 and 16 This regimen is repeated two weeks later Between each week of chemotherapy is a week break A course of chemotherapy consists of 28 days two weeks of chemotherapy and two 1-week breaks Patients may receive up to four courses total of 16 weeks unless their disease progresses or they cannot tolerate further doses Doses of the chemotherapy can be reduced if the side effects are too severe
Group 2 - Patients follow the same procedure as those in Group 1 for laparotomy CT imaging and IV chemotherapy with oxaliplatin 5-fluorouracil and leucovorin They do not receive CHPP or chemotherapy into the abdomen
All patients undergo repeat imaging tests six weeks after surgery and at the conclusion of the intravenous IV chemotherapy They return for a physical examination and CT scans every three months for the first year every four months for the next two years and then every six months for up to five years after treatment They are also asked to complete quality of life questionnaires before and after surgery at the completion of chemotherapy and at every follow-up visit
Surgical removal of tumors plus heated chemotherapy during surgery followed by one dose of chemotherapy 7 to 12 days after surgery followed 3 weeks later by 4 months of chemotherapy or
Surgical removal of tumors followed by 4 months of chemotherapy starting 1 month after surgery
Patients 18 years of age and older with peritoneal carcinomatosis may be eligible for this study Candidates are screened with a medical history physical examination and blood tests chest X-ray and computed tomography CT scans review of pathology slides electrocardiogram EKG bone scan and brain magnetic resonance imaging MRI as needed and laparotomy Laparatomy is a surgical procedure in which an incision is made in the abdomen to look at the amount and location of tumors in the abdominal cavity Patients whose surgery reveals that the tumors cannot be removed are taken off study Those eligible for the study have their tumors removed during this screening laparotomy as part of the study procedure as follows
All participants undergo laparotomy and removal of as much tumor as possible as described above Patients are then randomly assigned to one of two treatment groups
Group 1 - During laparotomy after tumor removal patients receive continuous hyperthermic peritoneal perfusion CHPP with the anti-cancer drug cisplatin For CHPP the cisplatin solution is heated and delivered to the abdomen through a catheter plastic tube washed through the abdomen for 90 minutes and then drained out of the body through another catheter At the close of surgery a small catheter called a Tenckhoff catheter is left in the abdomen and brought out through the skin Between days 7 and 12 after surgery one dose of fluorouracil and paclitaxel chemotherapy is delivered through this catheter The catheter is removed following complete recovery from surgery and the patient is discharged from the hospital Four to 6 weeks after the surgery patients have CT scans of the chest pelvis and abdomen and then begin intravenous IV through a vein chemotherapy with oxaliplatin 5-fluorouracil 5-FU and leucovorin The chemotherapy is given in 4-week courses as follows oxaliplatin on day 1 infused over 2 hours through a vein in the arm or neck leucovorin on days 1 and 2 infused over 2 hours followed by 5-fluorouracil over 22 hours leucovorin and 5-FU repeated two weeks later on days 15 and 16 This regimen is repeated two weeks later Between each week of chemotherapy is a week break A course of chemotherapy consists of 28 days two weeks of chemotherapy and two 1-week breaks Patients may receive up to four courses total of 16 weeks unless their disease progresses or they cannot tolerate further doses Doses of the chemotherapy can be reduced if the side effects are too severe
Group 2 - Patients follow the same procedure as those in Group 1 for laparotomy CT imaging and IV chemotherapy with oxaliplatin 5-fluorouracil and leucovorin They do not receive CHPP or chemotherapy into the abdomen
All patients undergo repeat imaging tests six weeks after surgery and at the conclusion of the intravenous IV chemotherapy They return for a physical examination and CT scans every three months for the first year every four months for the next two years and then every six months for up to five years after treatment They are also asked to complete quality of life questionnaires before and after surgery at the completion of chemotherapy and at every follow-up visit
Detailed Description:
Patients with low-grade gastrointestinal adenocarcinoma and peritoneal carcinomatosis will undergo laparotomy and tumor debulking Patients will be randomized at completion of tumor debulking to receive continuous hyperthermic peritoneal perfusion HIPECformerly CHPP with 250 mgm2 cisplatin and an intraperitoneal dwell of 5-fluorouracil 800 mgm2 and paclitaxel 125 mgm2 once between postoperative day 7 and 12 All patients will receive systemic oxaliplatin leucovorin and infusional 5-FU every other week of every four weeks starting 4 to 6 weeks after operation and continuing for four cycles The major endpoint is time to intraperitoneal tumor progression and survival in patients stratified based on history of previous treatment with systemic chemotherapy yes vs no history of prior debulking surgery and ability to optimally vs suboptimally debulk intraperitoneal tumor burden
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-0085 | None | None | None |