Gastrointestinal Neoplasm Clinical Trial
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
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.
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 (HIPEC,formerly CHPP) with 250 mg/m^2 cisplatin and an intraperitoneal dwell of 5-fluorouracil 800 mg/m^2 and paclitaxel 125 mg/m^2 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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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