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Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer Clinical research trials and Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer. Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer  Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer
Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer
For Condition: recurrent colon cancer,adenocarcinoma of the rectum,liver metastases,peritoneal cavity cancer,adenocarcinoma of the colon,recurrent rectal cancer
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of second-look surgery with or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who have colorectal cancer that is recurrent to the peritoneum.
Details: OBJECTIVES: I. Compare the effect of second look surgery with or without intraperitoneal mitomycin and fluorouracil on the 3 year survival rate of patients with colorectal cancer who are at high risk for peritoneal cavity cancer. II. Compare the quality of life of patients treated with these regimens. III. Compare the toxicity of these regimens in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, risk group, presence of symptoms (yes vs no), and isolated disease (yes vs no). After primary surgery, all patients receive 6 months of chemotherapy consisting of leucovorin calcium IV followed by fluorouracil IV over 10 minutes on days 1-5 every 4 weeks. Patients then undergo second look surgery or laparoscopy at 8-12 months. Second look surgery or laparoscopy may be performed earlier if markers increase progressively for unknown reasons or symptoms of peritoneal cancer occur. Patients with recurrent disease that can be resected are randomized to one of two treatment arms. Patients with no residual disease or with unresectable disease are followed for survival. Arm I: Patients undergo complete resection of all detectable lesions followed immediately by intraperitoneal (IP) mitomycin on day 0 and fluorouracil IP on days 1-4. Patients also receive systemic chemotherapy consisting of leucovorin calcium IV over 2 hours and fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Systemic chemotherapy repeats every 2 weeks for 6 months. Arm II: Patients undergo complete or partial resection and then receive systemic chemotherapy as in arm I. Quality of life is assessed at baseline and then every 4 months for 3 years. All patients (including nonrandomized patients) are followed every 4 months for 3 years. PROJECTED ACCRUAL: A total of 152 patients (76 randomized) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Primary diagnosis of adenocarcinoma of the colon or rectum and meeting one of the following risk criteria during the primary surgery: Perforated bowel (spontaneous or not); Occlusion; Peritoneal deposits; Invasion of serosa of more than 4 cm diameter; Concurrent ovarian metastases - Randomization eligibility: Presence of proven recurrent peritoneal disease (only one micronodule of 1 mm sufficient) at second look laparotomy; Total resection of macroscopic lesions possible (local recurrence, lymph node or hepatic metastases) --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy - Chemotherapy: No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy - Radiotherapy: No concurrent anticancer radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 70 and under - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: WBC at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Not specified - Renal: Creatinine no greater than 1.4 mg/dL - Cardiovascular: No cardiac condition that would increase surgical risk - Pulmonary: No pulmonary condition that would increase surgical risk - Other: No other condition that would increase surgical risk; No other malignancy within the past 5 years except basal cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DominiqueElias, Study Chair, Federation Nationale des Centres de Lutte Contre le Cancer
Centre Hospitalier Regional de Lille
Lille, , 59037
France
CHU Sart-Tilman
LIEGE, , B-4000
Belgium
Centre Leon Berard
Lyon, , 69373
France
CHR Hotel Dieu
Nantes, , 44093
France
C.H.R. de Nimes - Hopital Caremeau
Nimes, , 30000
France
Institut J. Paoli and I. Calmettes
Marseille, , 13273
France
Centre Hospitalier Universitaire de Dijon
Dijon, , 21033
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , 34298
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Centre Paul Strauss
Strasbourg, , 67085
France
CHR D'Orleans - Hopital de la Source
Orleans, , 45067
France
Institut Gustave Roussy
Villejuif, , F-94805
France
CHU Ambroise Pare
Boulogne-Billancourt, , F-92104
France
Centre Hospitalier Universitaire
Reims, , 51092
France
Institut Bergonie
Bordeaux, , 33076
France
Hopital L'Archet - 2
Nice, , F-06202
France
CHR de Besancon - Hopital Jean Minjoz
Besancon, , 25030
France
CHU de la Timone
Marseille, , 13385
France
Additional Information:
Study ID Numbers: CDR0000067833; EU-20010,FRE-FNCLCC-97018
Study Start Date: November 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005944
Other Recurrent Colon Cancer Studies:
1. Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
2. Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
3. Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
4. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
5. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
Related Studies:
Other recurrent colon cancer Clinical Trials
Other Clinical Trials
Other Dijon Clinical Trials
Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer
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