Efficacy of Neoadjuvant Thermo-Radio-chemotherapy for Locally Advanced Rectal Cancer Before Laparoscopic Total Mesorectal Excision: Prospective Phase II Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Samsung Medical Center
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Curative Resection Rate of Laparoscopic TME
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Thermo-radio-chemotherapy arm
Hyperthermia with concurrent chemo-radiation therapy
Intervention: Hyperthermia with concurrent chemo-radiation therapy (Radiation)
Outcomes
Primary Outcomes
Curative Resection Rate of Laparoscopic TME
Time Frame: expected average of 6 weeks after neoadjuvant treatement
Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament
Pathologic Response of Thermo-radio-chemotherapy
Time Frame: expected average of 6 weeks after neoadjuvant treatement
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)
Adverse Event of Laparoscopic TME and Hyperthermia With CCRT
Time Frame: expected average of 16 weeks after neoadjuvant treatement
Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT
Secondary Outcomes
- Rate of Open TME(expected average of 6 weeks after neoadjuvant treatement)
- Pathologic Complete Response of Hyperthermia With CCRT(expected average of 6 weeks after neoadjuvant treatement)
Investigators
Park Hee Chul
Assocate Professor
Samsung Medical Center