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Trial record 3 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

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ClinicalTrials.gov Identifier: NCT02882269
Recruitment Status : Not yet recruiting
First Posted : August 29, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant chemotherapy with postoperative chemotherapy in patients with resectable locally advanced colon cancer

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Postoperative chemotherapy Drug: Neoadjuvant chemotherapy Phase 2 Phase 3

Detailed Description:

For resectable locally advanced colon cancer, the preferred treatment is colectomy with en bloc removal of the regional lymph nodes followed by chemotherapy of about 6 months. However, surgery may postpone the administration of chemotherapy due to postoperative complications such as anastomosis leakage, abdominal infection, thus leads to a poor survival. Some scholars suggested that for patients with locally advanced colon cancer, chemotherapy given before surgery might shrink or downstage tumor, facilitate surgery and promote a better oncological outcome. Whether adjuvant chemotherapy benefits these patients with better outcome still remains controversial.

In this study, eligible patients will be randomly allocated to receive either adjuvant chemotherapy or not. For patients receiving adjuvant chemotherapy, surgery will be performed 3-4 weeks later. Preoperative and postoperative chemotherapy will be given for a total of about 6 months. For patients receiving no preoperative chemotherapy, chemotherapy will be given for about 6 months postoperatively. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial to Investigate the Effect of Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer
Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Postoperative chemotherapy
Patients receive 6 months of chemotherapy after surgery.
Drug: Postoperative chemotherapy
Locally advanced colon cancer patients will receive surgery first, followed by 6 months of chemotherapy. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.
Other Name: drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy

Experimental: Neoadjuvant chemotherapy
Patients receive 3-4 cycles of chemotherapy before surgery. Preoperative and postoperative chemotherapy will be given for a total of 6 months.
Drug: Neoadjuvant chemotherapy
Neoadjuvant chemotherapy will be given to locally advanced colon cancer patients for 3-4 cycles. Surgery will be performed between 3 to 4 weeks subsequent to the last cycle of chemotherapy. After surgery, additional chemotherapy will be given. Preoperative and postoperative chemotherapy will be given for a total of 6 months. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.
Other Name: drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy




Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]
  2. recurrence-free survival [ Time Frame: 3 years ]
  3. local recurrence rate [ Time Frame: 3 years ]
  4. length of postoperative hospital stay [ Time Frame: 30 days ]
    Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.

  5. early complication rate [ Time Frame: 30 days ]
    Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day 30. Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.

  6. operative time [ Time Frame: 1 day ]
  7. number of lymph nodes retrieved [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suitable for curative surgery between 18 to 80 years old;
  • American Society of Anesthesiologists(ASA) grade I-III;
  • Pathological diagnosis of adenocarcinoma;
  • Tumor located between the cecum and sigmoid colon;
  • Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
  • Informed consent;
  • No preoperative chemoradiotherapy;
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria:

  • Pregnant patient;
  • History of psychiatric disease;
  • Use of systemic steroids;
  • Simultaneous multiple primary colorectal cancer;
  • Preoperative imaging examination results show:

    1. distant metastasis;
    2. unable to perform R0 resection;
  • Postoperative pathology of T1-T2 N0;
  • History of any other malignant tumor in recent 5 years;
  • Patients need emergency operation: mechanic ileus, perforation.

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): NCT02882269


Contacts
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Contact: Yueming Sun, PhD 02568136026 jssym@vip.sina.com

Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Director: Fumin Zhang, Professor Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02882269     History of Changes
Other Study ID Numbers: CRSYM201608
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
locally advanced colon cancer
neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents