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

Samsung Medical Center

Status: Terminated

Conditions: Locally Advanced Rectal Cancer

Treatments: Radiation: Hyperthermia with concurrent chemo-radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02290574

2014-10-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Thermo-radio-chemotherapy arm

Experimental group

Description:

Hyperthermia with concurrent chemo-radiation therapy

Treatment:

Radiation: Hyperthermia with concurrent chemo-radiation therapy