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

NCT ID: NCT02290574

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-03-31

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.

Conditions

Locally Advanced Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thermo-radio-chemotherapy arm

Hyperthermia with concurrent chemo-radiation therapy

Group Type: EXPERIMENTAL

Hyperthermia with concurrent chemo-radiation therapy

Intervention Type: RADIATION

Interventions

Hyperthermia with concurrent chemo-radiation therapy

Intervention Type: RADIATION

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Park Hee Chul

Assocate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee Chul Park, Professor

Role: STUDY_CHAIR

Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2014-10-019

Identifier Type: -

Identifier Source: org_study_id