The investigators start this prospective study to evaluate the efficacy of laparoscopic total mesorectal excision after concurrent chemo-radiation therapy with hyperthermia in locally advanced rectal cancer.
The current standard treatment of locally advanced rectal cancer is neoadjuvant concurrent chemo-radiation therapy (CCRT) followed by total mesorectal excision (TME). Recently, laparoscopic surgery is getting substitute open surgery based on the advantages of early recovery, short admission, less pain, less blood loss, and little scar without compromising oncologic outcomes. It is reported that hyperthermia is effective in synthetic (S) phase, Low oxgen pressure, acidic, and low perfusion site which are known as radio-resistant. Because of these characteristics, it considered as the most valuable radiosensitizer in cancer treatment, theoretically. Furthermore, mild hyperthermia (41 to 41.5 ºC) can promote tumor reoxygenation. Based on those background, the investigators start this prospective study to evaluate the efficacy of laparoscopic TME after CCRT with hyperthermia in locally advanced rectal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Samsung Medical Center
Seoul, South Korea
Curative Resection Rate of Laparoscopic TME
Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament
Time frame: expected average of 6 weeks after neoadjuvant treatement
Pathologic Response of Thermo-radio-chemotherapy
The pathologic response was assessed according to the Dworak's system. The pathologic response grades were as follows: grade 0, no response; grade 1, dominant tumor mass with obvious fibrosis, vasculopathy, or both (minimal response); grade 2, dominant fibrotic changes with a few easy-to-find tumor cells or groups (moderate response); grade 3, few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance (near complete response); and grade 4, no viable tumor (complete response)
Time frame: expected average of 6 weeks after neoadjuvant treatement
Adverse Event of Laparoscopic TME and Hyperthermia With CCRT
Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT
Time frame: expected average of 16 weeks after neoadjuvant treatement
Rate of Open TME
Rate of open TME was measured as ten percent
Time frame: expected average of 6 weeks after neoadjuvant treatement
Pathologic Complete Response of Hyperthermia With CCRT
Pathologic complete response of hyperthermia with CCRT was achieved in 20% of participants
Time frame: expected average of 6 weeks after neoadjuvant treatement
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