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

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.

Study Overview

• Status: Terminated
• Conditions: Locally Advanced Rectal Cancer
• Intervention / Treatment: Radiation: Hyperthermia with concurrent chemo-radiation therapy

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermo-radio-chemotherapy arm; Hyperthermia with concurrent chemo-radiation therapy	Radiation: Hyperthermia with concurrent chemo-radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Curative Resection Rate of Laparoscopic TME	Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament	expected average of 6 weeks after neoadjuvant treatement
Pathologic Response of Thermo-radio-chemotherapy	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)	expected average of 6 weeks after neoadjuvant treatement
Adverse Event of Laparoscopic TME and Hyperthermia With CCRT	Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT	expected average of 16 weeks after neoadjuvant treatement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Open TME	Rate of open TME was measured as ten percent	expected average of 6 weeks after neoadjuvant treatement
Pathologic Complete Response of Hyperthermia With CCRT	Pathologic complete response of hyperthermia with CCRT was achieved in 20% of participants	expected average of 6 weeks after neoadjuvant treatement

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Hee Chul Park, Professor, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 13, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 2014-10-019