Colonic Neoplasms
Conditions
Keywords
Colonic Neoplasms, Laparoscopic Surgery, Neoadjuvant chemotherapy, T4
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
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.
Interventions
DRUGXELOX or FOLFOX chemotherapy
4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery
Sponsors
Shanghai Jiao Tong University School of Medicine
Zhejiang University
Tongji University
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 3-year | calculated from the date of surgery to the date of recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3-year | calculated from the date of diagnosis to the date of death from any cause |
| Adverse events (mortality and morbidity) | 3-month | Number of participants with treatment-related adverse events assessed by CTCAE v4.0 |
| The proportion of completion of laparoscopic surgery | 1-month | The number of completion of laparoscopic surgery/the number of participants |
Contacts
Primary ContactJiong Wu, MD,PhD
Backup ContactWei Jin, MD,PhD
Outcome results
None listed