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Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer

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ClinicalTrials.gov Identifier: NCT02777437
Recruitment Status : Not yet recruiting
First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Sponsor:
Collaborators:
Shanghai Jiao Tong University School of Medicine
Zhejiang University
Tongji University
Information provided by (Responsible Party):
LI XIN-XIANG, Fudan University

Brief Summary:

Primary Outcome Measures: Disease free survival

Secondary Outcome Measures:

Overall survival

Adverse events (Mortality, morbidity)

The proportion of completion of Laparoscopic Surgery

Estimated Enrollment: Oct, 2016

Study Start Date: Oct, 2016

Estimated Study Completion Date: Oct, 2019

Estimated Primary Completion Date: Oct, 2021

Groups/Cohorts

  1. Laparoscopic surgery for T4 colon cancers
  2. Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Drug: XELOX or FOLFOX chemotherapy Phase 2 Phase 3

Detailed Description:

Investigators' previous studies indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy may be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. The survival outcome of T4 colon cancers still dismays clinicians and patients. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer. Optimal systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Besides, the shrinkage of primary tumor before surgery may reduce the risk of incomplete surgical excision and the risk of shedding of tumor cells during surgery. The aim of the present study is to compare the short-and long-term survival outcomes between laparoscopic surgery alone and laparoscopic surgery with 4 cycles of neoadjuvant chemotherapy for T4 colon cancer as well as the mortality and the morbidity.

The number of patients, which needs to get power of 80%, is 1960. The average numbers of patients needs to reach approximately 200, and that of surgical centers needs to reach 10.

Arrangements in the preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

Globally,the disease free survival rate (chemotherapy and surgery), mortality (chemotherapy and surgery), the morbidity (chemotherapy and surgery) and the proportion of completion of laparoscopic surgery of the two surgical strategies will be analized and compared.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
No Intervention: Laparoscopic surgery
Patients with T4 colon cancer receive laparoscopic surgery only.
Experimental: Neoadjuvantive chemotherapy + Laparoscopic surgery
Patients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery.
Drug: XELOX or FOLFOX chemotherapy
4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery
Other Name: Xeloda+ OXA or OXA+ 5-FU




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3-year ]
    calculated from the date of surgery to the date of recurrence


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3-year ]
    calculated from the date of diagnosis to the date of death from any cause

  2. Adverse events (mortality and morbidity) [ Time Frame: 3-month ]
    Number of participants with treatment-related adverse events assessed by CTCAE v4.0

  3. The proportion of completion of laparoscopic surgery [ Time Frame: 1-month ]
    The number of completion of laparoscopic surgery/the number of participants



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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:

  • Able to provide written informed consent
  • Histologically confirmed diagnosis of colon carcinoma
  • CT or MRI verified as T4 colon cancer without involvement of other organs.
  • Without multiple lesions other than carcinoma in situ
  • Tumor size < 8 cm
  • No bowel obstruction
  • Sufficient organ function
  • No history of gastrointestinal surgery
  • 18 years of age or older
  • Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
  • Operable patients
  • Completion of neoadjuvant systemic chemotherapy

Exclusion Criteria:

  • Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
  • No intention to finish neoadjuvantive systemic therapy
  • Unstable or uncompensated respiratory or cardiac disease
  • Serious active infections
  • Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
  • Stomatitis or ulceration in the mouth or gastrointestinal tract
  • Severe diarrhea
  • Peripheral sensory neuropathy with functional impairment

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): NCT02777437


Contacts
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Contact: Jiong Wu, MD,PhD 0086-21-34610367 18918298120@163.com
Contact: Wei Jin, MD,PhD 0086-21-64175590 ext 25022 34865893@qq.com

Sponsors and Collaborators
Fudan University
Shanghai Jiao Tong University School of Medicine
Zhejiang University
Tongji University
Investigators
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Principal Investigator: Xinxiang Li, MD,PhD Fudan University

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Responsible Party: LI XIN-XIANG, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02777437     History of Changes
Other Study ID Numbers: FuDanLapT4
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Keywords provided by LI XIN-XIANG, Fudan University:
Colonic Neoplasms
Laparoscopic Surgery
Neoadjuvant chemotherapy
T4
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases