Clinical trial NCT02290574: Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial
Official title: Efficacy of Neoadjuvant Thermo-Radio-chemotherapy for Locally Advanced Rectal Cancer Before Laparoscopic Total Mesorectal Excision: Prospective Phase II Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Locally Advanced Rectal Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Curative Resection Rate of Laparoscopic TME
timeFrame: expected average of 6 weeks after neoadjuvant treatement
measure: Pathologic Response of Thermo-radio-chemotherapy
timeFrame: expected average of 6 weeks after neoadjuvant treatement
measure: Adverse Event of Laparoscopic TME and Hyperthermia With CCRT
timeFrame: expected average of 16 weeks after neoadjuvant treatement
Secondary outcomes:
measure: Rate of Open TME
timeFrame: expected average of 6 weeks after neoadjuvant treatement
measure: Pathologic Complete Response of Hyperthermia With CCRT
timeFrame: expected average of 6 weeks after neoadjuvant treatement
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Hee Chul Park, Professor
role: STUDY_CHAIR
References: