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Trial record 79 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for mCRC

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ClinicalTrials.gov Identifier: NCT03792269
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jing Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary:
XELOX as first-line treatment regimen has limited efficacy against patients with metastatic colorectal cancer (mCRC). Peritoneal metastasis is one of the most lethal factor for mCRC. Intraperitoneal chemotherapy has became a widely accepted strategy in the treatment of peritoneal dissemination. We hypothesized that combined multi-channel administration, such as intraperitoneal chemotherapy, oral chemotherapy, and intravenous chemotherapy, can produce better results than XELOX for first-line treatment for mCRC patients.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Chemotherapy Effect Chemotherapeutic Toxicity Drug: Irinotecan Drug: Oxaliplatin Drug: Capecitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase II Clinical Trial Comparing the Efficacy and Safety of Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for Metastatic Colorectal Cancer
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Multi-channel chemotherapy
Patients will receive intraperitoneal irinotecan (50mg, d1, q2w).
Drug: Irinotecan
intraperitoneal

Active Comparator: Control Group
Patients will receive intravenous oxaliplatin (130mg/m^2, d1, q3w), and oral capecitabine (1.0g, d1-14, q3w).
Drug: Oxaliplatin
intravenous

Drug: Capecitabine
Other Name: Oral




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to 1 year ]
    PFS is the period between the first course of treatment to disease recurrence. The follow-up work will be performed every 6 weeks until disease recurrence or loss to follow-up.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to 2 years ]
    OS is the period between the first course of treatment to death. The follow-up work will be performed every 3 months until death or loss to follow-up.

  2. Objective Response Rate (ORR) [ Time Frame: up to 24 weeks ]
    CT/MRI will be performed every 2 cycles of treatment for short-term efficacy. evaluation

  3. Adverse Events (AE) [ Time Frame: up to 2 years ]
    Adverse effects will be recorded during the whole treatment.



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

Inclusion Criteria:

Patients must have histologically confirmed adenocarcinoma of clorectal with inoperable locally advanced or metastatic disease, not amenable to curative therapy.

Patients must have measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1), assessed using imaging techniques (CT or MRI).

Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to chemotherapy, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 6 months after therapy completed Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1 or 2. Absolute neutrophil count (ANC) >=1,500/ul Platelets (PLT) >=75,000/ul Serum bilirubin <= 1.5 × upper limit of normal (ULN) Aspartate transaminase (AST) or alanine aminotransferase (ALT) <= 2.5 × ULN (or <= 5 × ULN in patients with liver metastases) Alkaline phosphatase <= 2.5 × ULN (or <= 5 × ULN in patients with liver metastases, or <= 10 × ULN in patients with bone but no liver metastases) Albumin >= 25 g/L. Creatinine clearance >= 60 mL/min. Life expectancy of at least 3 months. Signed informed consent.

Exclusion Criteria:

Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).

Patients with active (significant or uncontrolled) gastrointestinal bleeding. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE 4.0.

Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.

History of documented congestive heart failure; angina pectoris requiring medication;evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.

Baseline left ventricular ejection fraction (LVEF) < 50% (measured by echocardiography or MUGA).

Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.

Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).

Clinically significant hearing abnormality. Known dihydropyrimidine dehydrogenase (DPD) deficiency. History or clinical evidence of brain metastases. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.

Positive serum pregnancy test in women of childbearing potential. Received any investigational drug treatment within 4 weeks of start of study treatment.

Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recovered from any acute toxicity;prior adjuvant radiotherapy is allowed if complete at least 6 months ).

Major surgery within 4 weeks of start of study treatment, without complete recovery.

Patients with known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).

Known hypersensitivity to any of the study drugs.


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): NCT03792269


Contacts
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Contact: Jing Hu, M.D., P.hD 0086-13057668736 doctorhujing@hotmail.com
Contact: Xiaoping Qian, M.D., P.hD 0086-13851763162 qianxiaoping211@hotmail.com

Locations
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China, Jiangsu
The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Jing Hu, M.D., P.hD         
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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Study Chair: Jing Jing The Comprehensive Cancer Center of Nanjing Drum Tower Hospital

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Responsible Party: Jing Hu, investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03792269     History of Changes
Other Study ID Numbers: mCRC-PC
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors