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Trial record 85 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

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

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ClinicalTrials.gov Identifier: NCT02830139
Recruitment Status : Not yet recruiting
First Posted : July 12, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Bin Xiong, MD, Wuhan University

Brief Summary:
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 that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Colorectum Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) Procedure: Radical colorectal resection Drug: Oxaliplatin , Capecitabine Drug: Normal saline , Cisplatin , 5-Fu Phase 2

Detailed Description:

To determine the efficacy of HIPEC in the treatment of locally advanced colorectal cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical colorectal resection with lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical colorectal resection with lymphadenectomy. Patients in both groups receive 8 cycles of postoperative chemotherapy (XELOX) and are followed up for 5 years or until death.

The trial is designed as a prospective, randomized, open, multicenter and parallel group study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Colorectal Cancer During Radical Colorectal Resection
Study Start Date : July 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Radical colorectal resection without HIPEC
Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)
Procedure: Radical colorectal resection
radical colorectal resection with lymphadenectomy

Drug: Oxaliplatin , Capecitabine
XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.

Drug: Normal saline , Cisplatin , 5-Fu
Experimental: Radical colorectal resection with HIPEC
Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (XELOX)
Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)
Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery.

Procedure: Radical colorectal resection
radical colorectal resection with lymphadenectomy

Drug: Oxaliplatin , Capecitabine
XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    From the date of surgery to the date of death or to the end of follow-up


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 5 years ]
  2. distant metastasis rate [ Time Frame: 5 years ]
  3. peritoneal metastasis rate [ Time Frame: 5 years ]
  4. local recurrence rate [ Time Frame: 5 years ]
  5. complication rate [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological proved diagnosis of locally advanced colorectal cancer.
  • No evidence of distant metastases or peritoneal metastases.
  • Preoperative examination (CT/MRI) demonstrated resectable colorectal cancer with T3-T4 stage.
  • Eligible for radical colorectal resection with lymphadenectomy.
  • Have not received cytotoxic chemotherapy or radiotherapy.
  • Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

  • Existence of distant metastasis or peritoneal metastasis during surgery (M1).
  • Any previous chemotherapy or radiotherapy
  • Active systemic infections
  • Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
  • Female patients who are pregnant or breast feeding

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Responsible Party: Bin Xiong, MD, Cancer Center of Wuhan University, Wuhan University
ClinicalTrials.gov Identifier: NCT02830139     History of Changes
Other Study ID Numbers: WuhanU_HIPEC_colon
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Capecitabine
Fever
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Body Temperature Changes
Signs and Symptoms
Cisplatin
Oxaliplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action