Colorectal Cancer

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Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Standard Anti-Vomiting Medicine During the First Course of Chemotherapy

Recruitment status: 
Completed

RATIONALE: Learning how often patients experience nausea and vomiting after receiving anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better treatment and improve patients' quality of life. PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-vomiting medicine during the first course of chemotherapy.

Background information
Trial ID: 
NCT00729677
Other unique IDs: 
CDR0000599895
BIMCP-NV-SURVEY
BIMCP-IRB-37-04
MERCK-BIMCP-NV-SURVEY
Official title: 

Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-Based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer

Detailed description: 

OBJECTIVES:

  • To assess the prevalence of delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-emetic medications during the first course of an oxaliplatin-based chemotherapy regimen (mFOLFOX6 or FOLFOX7).

Number to be enrolled: 
100 patients

Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer

Trial phase: 
Phase III
Recruitment status: 
Recruiting

RATIONALE: Laparoscopic-assisted resection is a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether laparoscopic-assisted resection is more effective than open resection in treating patients with rectal cancer. PURPOSE: This randomized phase III trial is studying laparoscopic-assisted resection to see how well it works compared with open resection in treating patients with stage IIA, stage IIIA, or stage IIIB rectal cancer.

Background information
Trial ID: 
NCT00726622
Other unique IDs: 
CDR0000601816
ACOSOG-Z6051
Official title: 

A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer

Detailed description: 

OBJECTIVES: Primary

  • To test the hypothesis that laparoscopic-assisted resection is not inferior to open resection, based on a composite primary endpoint of oncologic factors that are indicative of a safe and feasible surgical resection, in patients with stage IIA, IIIA, or IIIB rectal cancer.

Number to be enrolled: 
650 patients

FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer

Trial phase: 
Phase III
Recruitment status: 
Recruiting

This study is a randomized multi-center trial that will assess the effect of adding SIRT, using SIR-Spheres microspheres, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

Background information
Trial ID: 
NCT00724503
Other unique IDs: 
STX0206
Official title: 

Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

Detailed description: 

 

Number to be enrolled: 
318 patients
Acronym: 
SIRFLOX

Allogeneic Whole Cell Cancer Vaccine for Metastatic Epithelial Tumors

Trial phase: 
Phase I
Recruitment status: 
Not yet recruiting

This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with colorectal, gastric, ovarian, breast or lung epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals . This protocol is expected to prolong survival of metastatic epithelial cancer patients.

Background information
Trial ID: 
NCT00722228
Other unique IDs: 
0359-08-HMO-CTIL
Official title: 

 

Detailed description: 

 

Number to be enrolled: 
0 patients

Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

Trial phase: 
Phase II
Recruitment status: 
Recruiting

This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.

Background information
Trial ID: 
NCT00721916
Other unique IDs: 
Taiho10020390
Official title: 

Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer

Detailed description: 

 

Number to be enrolled: 
106 patients

Second-Line Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer Who Have Received First-Line Chemotherapy and Bevacizumab

Trial phase: 
Phase III
Recruitment status: 
Recruiting

RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with or without bevacizumab in treating metastatic colorectal cancer. PURPOSE: This randomized phase III trial is studying second-line combination chemotherapy to see how well it works compared with or without bevacizumab in treating patients with metastatic colorectal cancer who have received first-line chemotherapy and bevacizumab.

Background information
Trial ID: 
NCT00720512
Other unique IDs: 
CDR0000598567
GONO-BEBYP-ASL607LIOM03
GONO-AIFA - FARM5C4FB4
EUDRACT:2007-002886-11
Official title: 

AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE III STUDY OF SECOND-LINE CHEMOTHERAPY WITH OR WITHOUT BEVACIZUMAB IN METASTATIC COLORECTAL CANCER PATIENTS WHO HAVE RECEIVED FIRST-LINE CHEMOTHERAPY PLUS BEVACIZUMAB.

Detailed description: 

OBJECTIVES: Primary

  • To compare the progression-free survival of second-line chemotherapy with or without bevacizumab in patients with metastatic colorectal cancer who have received first-line chemotherapy with bevacizumab.

Secondary

  • To compare the overall survival, response rate, and safety profile of second-line chemotherapy of these regimens in these patients.
  • To conduct pharmacogenomics assessment of candidate variants in the VEGF gene and evaluate their association with progression-free survival and other study outcomes.

Number to be enrolled: 
262 patients

Combination Chemotherapy and Bevacizumab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Trial phase: 
Phase III
Recruitment status: 
Recruiting

RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens given together with bevacizumab to see how well they work as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Background information
Trial ID: 
NCT00719797
Other unique IDs: 
CDR0000598582
GONO-TRIBE
ASL608LIOM04
EUDRACT:2008-001537-10
Official title: 

A Phase III Randomized Trial of FOLFOXIRI + Bevacizumab Versus FOLFIRI + Bevacizumab as First- Line Treatment for Metastatic Colorectal Cancer.

Detailed description: 

OBJECTIVES: Primary

  • To compare the progression-free survival of bevacizumab in combination with oxaliplatin, irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFOXIRI) versus bevacizumab in combination with irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with unresectable, metastatic colorectal cancer.

Number to be enrolled: 
450 patients

Study of Irinotecan Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer

Trial phase: 
Phase I
Recruitment status: 
Recruiting

Open-label phase 1b trial. Study treatment will be administered in 3 week cycles. There are two distinct parts in this study:

  • Part 1: Dose escalation from IMO-2055
  • Part 2: Once a recommended phase 2 dose is found additional tolerability and pharmacodynamics will be explored

Background information
Trial ID: 
NCT00719199
Other unique IDs: 
IMO-2055-210
Official title: 

Open-Label Phase 1b Study of Irinotecan Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer Who Have Progressed Following Chemotherapy for Advanced or Metastatic Disease

Detailed description: 
  • Part 1: Dose escalation of IMO-2055, including 4 dose groups. Once a recommended phase 2 dosage (RP2D) of IMO-2055 given concomitantly with irinotecan and cetuximab is found the selected cohort will be expanded by an additional 6 to 9 patients (to a total of 12 patients) for confirmation of the RP2D and combination treatment regimen.
  • Part 2: A final cohort of 12 patients (Cohort 6) will be enrolled simultaneously to explore tolerability and pharmacodynamics in patients treated with the RP2D of IMO-2055 in combination with irinotecan with cetuximab.
Number to be enrolled: 
50 patients

Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-Based Therapy

Recruitment status: 
Recruiting

This is a study to determine how much nausea and or vomiting is caused by irinotecan-based chemotherapy in patients with colorectal cancer. Patients with colorectal cancer scheduled to receive their first cycle of an irinotecan-based chemotherapy regimen are eligible. Any chemotherapy agents administered in combination with irinotecan must have low-minimal potential to cause nausea and or vomiting. Examples of acceptable regimens would be irinotecan in combination with infusional fluorouracil and leucovorin (FOLFRI) with or without bevacizumab and irinotecan in combination with cetuximab. Patients who have received prior non-irinotecan-based chemotherapy are eligible providing they experienced no vomiting and no greater than mild nausea with their prior chemotherapy.

Background information
Trial ID: 
NCT00713128
Other unique IDs: 
00455
Official title: 

Prospective Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-Based Therapy

Detailed description: 

Irinotecan is a camptothecin analog which exerts its cytotoxic effects by forming a covalent complex with topoisomerase I and DNA, resulting in inhibition of DNA re-ligation, accumulation of DNA double strand breaks and apoptotic cell death (1). Irinotecan is FDA approved for use in the front-line and second-line treatment of colorectal cancer. It has also demonstrated activity in a variety of other non-hematologic tumors. The recently updated ASCO antiemetic guidelines characterize irinotecan as having moderate emetic risk. (2).

Number to be enrolled: 
50 patients

Study of the Therapeutic Use of Language in Patients With Metastatic Colorectal Cancer

Recruitment status: 
Recruiting

The purpose of this study is to determine if the degree of agreement between patients and their physicians regarding the "story" of the illness correlates with improved patient symptom control and quality of life. Another goal of the study is to examine the actual language used by patients and physicians in a specific clinical situation.

Background information
Trial ID: 
NCT00711672
Other unique IDs: 
808231
Official title: 

Critical Negotiations: Narrative Agreement, Negotiation, and Register Use in Encounters Between Patients With Metastatic Colorectal Carcinoma and Their Oncologists

Detailed description: 

The purpose of this study is to investigate the co-created therapeutic narrative in scheduled office visits between adult patients with metastatic colorectal carcinoma and their medical oncologists in a community practice setting. The study will focus on the negotiation of the illness narrative and the semiotic (primarily linguistic) tools employed. The study will involve patients from a large community cancer center from Northeastern Pennsylvania (this center sees about 3,000 new patients each year).

Number to be enrolled: 
18 patients
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