Advertisement

Topics

Prospective Randomized Trial Evaluating Mandatory Second Look Surgery With HIPEC and CRS vs. Standard of Care in Subjects at High Risk of Developing Colorectal Peritoneal Metastases

2014-08-27 03:14:53 | BioPortfolio

Summary

Background:

- Survival rates for colorectal cancer depend on a number of factors, including the existence of tumors outside the colon and rectum. Patients who had tumors elsewhere in the abdomen (such as in the peritoneum or ovaries) when they were diagnosed, as well as patients who had bleeding or obstruction when they were diagnosed, have a high risk of cancer recurrence even after surgery or other treatment.

- If additional tumors are discovered early and removed while they are still small (often before they can show up on scans), survival rates may improve. In addition, patients who receive a heated chemotherapy solution delivered directly to the abdomen often have better treatment outcomes regardless of whether additional tumors were found. Further research can help determine the usefulness of both of these treatments in improving the outcomes of patients with colorectal cancer.

Objectives:

- To determine whether patients who have had surgery for colorectal cancer have improved outcomes after receiving additional surgery combined with direct chemotherapy, compared with those who receive the current standard of care.

Eligibility:

- Individuals at least 18 years of age who have had surgery for colorectal cancer within the past 14 months, who are considered to be at high risk for cancer recurrence, and whose current imaging scans show no signs of additional tumors.

Design:

- Participants will be divided into two treatment groups: a surgery group and a standard of care group.

- Participants who had surgery less than 11 months ago will be enrolled in a 3-month lead-in phase to receive standard follow-up care, including labs, scans, and physical examinations, before being randomized to a treatment group between 11 and 14 months after surgery. Participants who had surgery between 11 and 14 months ago will be randomized at the time of enrollment.

- Participants in the surgery group will have the following procedures within 2 weeks of randomization:

- Abdominal surgery where surgeons will look for and remove any tumors and take biopsies to check for cancer cells

- Heated chemotherapy, with three chemotherapy drugs administered directly to the abdomen

- In-patient recovery and follow-up visits beginning 3 to 6 weeks after discharge.

- Participants in the standard of care group will have the standard follow-up schedule for high-risk colorectal cancer patients:

- Clinic evaluations every 3 months for 2 year...

Description

BACKGROUND:

- Peritoneal carcinomatosis (PC) from colorectal cancer (CRC) treated with chemotherapy alone results in median survival of 5 to 13 months.

.-Approximately, 55% of high risk patients (Patients presenting with synchronous PC, ovarian metastases perforated primary, and emergency presentation with bleeding or obstructing lesions) will develop PC.

- Early PC is undetectable by conventional imaging.

- Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for early PC from CRC resulted in median survival of 48-63 months and 5 year survival of 51 %.

- This study is a prospective randomized trial designed to answer the question whether mandatory second look surgery (MSLS) with CRS and HIPEC will prolong overall survival when compared to the standard of care.

OBJECTIVES:

Primary Objective:

- To compare the overall survival of patients at high risk for developing PC from CRC who undergo M SLS + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care.

Secondary Objectives:

- To determine recurrence-free survival in both arms.

- To investigate selection criteria for patient who might benefit from a strategy of MSLS with CRS + HIPEC.

ELIGIBILITY:

- Patients who have undergone curative resection f or CRC who are at high risk for recurrence

- Patients who shown no evidence of disease at the time of enrollment

- Patients with ECOG less than or equal to 0-2 and suitable candidates for laparotomy, HIPEC and CRS.

DESIGN:

- Patients with CRC at high risk for developing PC who underwent curative surgery and subsequently received standard of care and remained NED for 12 months after primary surgery will be randomized into MSLS/CRS/HIPEC or continuing standard of care.

- HIPEC will be done using Oxaliplatin/5-FU/Leucovorin.

- Up to 100 patients will be enrolled to allow for 35 evaluable patients in each arm; accrual is expected to last 5 years.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Colorectal Carcinoma

Intervention

Laparotomy+ HIPEC +/- CRS

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda
Maryland
United States
20892

Status

Recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:53-0400

Clinical Trials [2352 Associated Clinical Trials listed on BioPortfolio]

HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. These patients may obtain survival benefit from radical colorectal resection and cytoreduc...

Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery

This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the standard...

Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma

The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carci...

Adjuvant HIPEC to Prevent Colorectal Peritoneal Metastases in High-risk Patients

The prognosis of peritoneal metastases from colorectal cancer has recently improved with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Although outcomes are ...

Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Colorectal Cancer

The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial is t...

PubMed Articles [4704 Associated PubMed Articles listed on BioPortfolio]

Metastatic Colorectal Cancer to the Peritoneum: Current Treatment Options.

Peritoneal metastases (PM) are common in advanced-stage colorectal cancer (CRC) patients representing the second most common metastatic site of CRC. In the past, this clinical situation was treated wi...

Is there an oncological interest in the combination of CRS/HIPEC for peritoneal carcinomatosis of HCC? Results of a multicenter international study.

Peritoneal metastasis (PM) of hepatocellular carcinoma (HCC) without distant spread are rare. The related prognosis is poor without standard treatment available. The role of cytoreduction surgery (CRS...

Expression of Plasma miRNA-221 in Colorectal Carcinoma Patients and its Diagnostic Significance in Comparison with p53 Expression.

Colorectal carcinoma development progresses through a sequence of normal mucosa-polyp-carcinoma. Early detection of premalignancy is crucial for improved outcomes. We evaluated the diagnostic performa...

Antiangiogenic Therapy in Colorectal Cancer.

Colorectal carcinoma is the third most common cancer worldwide. Approximately 20% of patients with colorectal cancer will have metastatic disease at the time of initial diagnosis, and approximately 30...

DNA mismatch repair protein deficient non-neoplastic colonic crypts: a novel indicator of Lynch syndrome.

Lynch syndrome is the most common form of hereditary colorectal carcinoma. However, establishing the diagnosis of Lynch syndrome is challenging, and ancillary studies that distinguish between sporadic...

Medical and Biotech [MESH] Definitions

Clusters of colonic crypts that appear different from the surrounding mucosa when visualized after staining. They are of interest as putative precursors to colorectal adenomas and potential biomarkers for colorectal carcinoma.

Human COLORECTAL CARCINOMA cell line.

Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.

Incision into the side of the abdomen between the ribs and pelvis.

Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).

More From BioPortfolio on "Prospective Randomized Trial Evaluating Mandatory Second Look Surgery With HIPEC and CRS vs. Standard of Care in Subjects at High Risk of Developing Colorectal Peritoneal Metastases"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...


Searches Linking to this Trial