Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial (NEOTREAT)

Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial

Efficacy of Neoadjuvant Thermo-Radio-chemotherapy for Locally Advanced Rectal Cancer Before Laparoscopic Total Mesorectal Excision: Prospective Phase II Trial

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.

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)

Inclusion Criteria: 20 years or older pathologically confirmed rectal cancer Eastern Cooperative Oncology Group performance status 0 to 2 Candidate of laparoscopic TME Optimal bone marrow function Locally advanced rectal cancer confirmed by magnetic resonance imaging Exclusion Criteria: Extrapelvic metastasis Previous pelvic irradiation Current status of pregnant or breast feeding Confirmed other malignancy within two years except thyroid cancer