Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total accrual of 203 was expected within approximately 5-6 years (59 patients for adenocarcinoma of gastrointestinal origin, other than low grade mucinous; 48 patients with low grade mucinous adenocarcinoma; and 96 patients with primary peritoneal mesothelioma).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Peritoneal Mesothelioma	Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
Low Grade Mucinous Adenocarcinoma	Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
Adenocarcinoma of Gastrointestinal Origin	Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.

Participant Flow:   Overall Study

	Peritoneal Mesothelioma	Low Grade Mucinous Adenocarcinoma	Adenocarcinoma of Gastrointestinal Origin
STARTED	83	48	57
Not Evaluable	21	9	23
COMPLETED	61	39	35
NOT COMPLETED	22	9	22

Reporting Groups

	Description
Peritoneal Mesothelioma	Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
Low Grade Mucinous Adenocarcinoma	Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
Adenocarcinoma of Gastrointestinal Origin	Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.

Baseline Measures

	Peritoneal Mesothelioma	Low Grade Mucinous Adenocarcinoma	Adenocarcinoma of Gastrointestinal Origin	Total
Number of Participants   [units: participants]	83	48	57	188
Age   [units: participants]
<=18 years	3	0	0	3
Between 18 and 65 years	71	43	52	166
>=65 years	9	5	5	19
Age   [units: years] Mean ± Standard Deviation	49.95  ± 14.12	50.48  ± 10.85	49.70  ± 11.78	50.01  ± 12.61
Gender   [units: participants]
Female	38	23	28	89
Male	45	25	29	99
Race/Ethnicity, Customized   [units: Participants]
White	69	38	54	161
Hispanic	6	0	3	9
African American	2	7	0	9
Asian American	4	3	0	7
Unknown	2	0	0	2
Region of Enrollment   [units: participants]
United States	83	48	57	188

1.  Primary:

Number of Participants With Disease-free Survival   [ Time Frame: On study date until the first scan with imageable disease, assessed up to 100 months or more. ]

2.  Primary:

Number of Participants With a Response   [ Time Frame: Patients were assessed every three months for one year and then every 6 months ]

3.  Primary:

Number of Participants With Adverse Events   [ Time Frame: only assessed during the perioperative period (i.e. up to 90 days following surgery) ]

4.  Secondary:

Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed   [ Time Frame: Perioperative day 7-12 after surgery ]

5.  Secondary:

Quality of Life Questionnaire Score   [ Time Frame: preop, 6 weeks postop and then 3, 6, 9, and 12 months the first year and then every 6 months until the patient is off study ]

6.  Secondary:

Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue   [ Time Frame: once during surgery ]