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Trial record 79 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)

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ClinicalTrials.gov Identifier: NCT02965248
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Guoxiang Cai, Fudan University

Brief Summary:
This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer

Condition or disease Intervention/treatment Phase
Locally Advanced Colorectal Cancer Drug: Standard adjuvant systemic chemotherapy Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin Phase 3

Detailed Description:
Peritoneum is one of the common sites of metastasis in advanced stage colorectal cancer patients, resulting in a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is effective to colorectal peritoneal metastasis and may play a significant role in reducing the risk of metachronous peritoneal metastasis among patients with locally advanced colorectal cancer. Oxaliplatin is routinely used for HIPEC in the Europe and Raltitrexed may be another ideal drug for HIPEC. The present phase II multicenter, randomized controlled trial is designed to evaluate the efficacy and safety of adjuvant HIPEC with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized Controlled Trial Designed to Evaluate the Efficacy and Safety of Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Raltitrexed or Oxaliplatin Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)
Study Start Date : November 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Active Comparator: Arm A
Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months.
Drug: Standard adjuvant systemic chemotherapy

Patients undergo radical surgery with standard adjuvant systemic chemotherapy (mFOLFOX6/CapeOx/sLV5FU2/Cape).

mFOLFOX6: oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

CapeOx: oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

sLV5FU2: leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

Cape: capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

Other Names:
  • adjuvant oxaliplatin, 5-FU, and leucovorin calcium (mFOLFOX6)
  • adjuvant oxaliplatin and capecitabine (CapeOx)
  • adjuvant 5-FU and leucovorin calcium (sLV5FU2)
  • adjuvant capecitabine (Cape)

Experimental: Arm B
Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Patients also undergo HIPEC with raltitrexed (3mg/m2) intraperitoneally for 60 minutes during surgery or within 10 days after the operation.
Drug: Standard adjuvant systemic chemotherapy

Patients undergo radical surgery with standard adjuvant systemic chemotherapy (mFOLFOX6/CapeOx/sLV5FU2/Cape).

mFOLFOX6: oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

CapeOx: oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

sLV5FU2: leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

Cape: capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

Other Names:
  • adjuvant oxaliplatin, 5-FU, and leucovorin calcium (mFOLFOX6)
  • adjuvant oxaliplatin and capecitabine (CapeOx)
  • adjuvant 5-FU and leucovorin calcium (sLV5FU2)
  • adjuvant capecitabine (Cape)

Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed
Raltitrexed (3 mg/m2) is added to the perfusate after attaining 42 degrees of inflow temperature and last for 60 minutes.
Other Name: Intraperitoneal raltitrexed 3 mg/m2

Experimental: Arm C
Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Patients also undergo HIPEC comprising oxaliplatin (130mg/m2) intraperitoneally during surgery and hyperthermia for 30 minutes, following leucovorin calcium (20mg/m2 intravenously) and 5-FU (400 mg/m2 intravenously)
Drug: Standard adjuvant systemic chemotherapy

Patients undergo radical surgery with standard adjuvant systemic chemotherapy (mFOLFOX6/CapeOx/sLV5FU2/Cape).

mFOLFOX6: oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

CapeOx: oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

sLV5FU2: leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

Cape: capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

Other Names:
  • adjuvant oxaliplatin, 5-FU, and leucovorin calcium (mFOLFOX6)
  • adjuvant oxaliplatin and capecitabine (CapeOx)
  • adjuvant 5-FU and leucovorin calcium (sLV5FU2)
  • adjuvant capecitabine (Cape)

Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin
Before the beginning of HIPEC, 5-FU 400 mg/m2 and leucovorin calcium 20 mg/m2 will be administered intravenously to potentiate oxaliplatin activity. Oxaliplatin (130 mg/m2) is added to the perfusate after attaining 42 degrees inflow temperature with a total of 30 minutes perfusion time.
Other Names:
  • I.V. leucovorin calcium 20 mg/m2
  • I.V. 5-FU 400 mg/m2
  • Intraperitoneal oxaliplatin 130 mg/m2




Primary Outcome Measures :
  1. peritoneal metastasis rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. liver metastasis rate [ Time Frame: 3 years ]
  2. disease free survival [ Time Frame: 3 years ]
  3. overall survival [ Time Frame: 5 years ]
  4. quality of life questionnaire [ Time Frame: 6 months ]
  5. Toxicity by NCI CTCAE v.4.0 [ 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:

  • Joined the study voluntarily and signed informed consent form
  • Eastern Cooperative Oncology Group performance status of 0 to 1
  • Life expectancy of more than 5 years
  • Colorectal adenocarcinoma / mucinous adenocarcinoma / signet ring cell cancer confirmed by histopathology
  • Stage T4NanyM0 cancer; or stage T3NanyM0 mucinous adenocarcinoma / signet ring cell cancer / adenocarcinoma with partly mucinous adenocarcinoma or signet ring cell cancer
  • R0 resection of colorectal cancer
  • Neutrophils (ANC) ≥ 1.5×10^9/L, Platelet count (Pt) ≥ 100× 10^9/L, Hemoglobin (Hb) ≥ 80 g/L, Hepatic function: ALT and AST ≤ 2.5 times upper limit of normal (ULN) and TBIL ≤ 1.5 times ULN, Renal function: creatinine ≤ 1.5 times ULN
  • Use of an effective contraceptive for adults to prevent pregnancy

Exclusion Criteria:

  • Rectal cancer below peritoneal reflection (≤ 8cm above the anal verge)
  • Other malignant tumors within the past 5 years, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived from radical treatment
  • Severe adhesion of peritoneal cavity impossible to separate
  • Abdominal infection
  • Allergic to raltitrexed, 5-FU, and oxaliplatin; Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  • Drug addiction, Alcoholism or AIDS
  • Impossible to tolerate the operation due to severe cardiac, lung, and vascular diseases
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965248


Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Guoxiang Cai, M.D. Ph.D.    +86 13611831623    gxcai@fudan.edu.cn   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Guoxiang Cai, M.D. Ph.D. Fudan University

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Responsible Party: Guoxiang Cai, Associate Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02965248     History of Changes
Other Study ID Numbers: 1608163-15
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Keywords provided by Guoxiang Cai, Fudan University:
Locally advanced colorectal cancer
Hyperthermic intraperitoneal chemotherapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Fluorouracil
Fever
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Body Temperature Changes
Signs and Symptoms
Calcium, Dietary
Leucovorin
Raltitrexed
Oxaliplatin
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents