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

NCT02290574 | Terminated Results DMC

• 1 other identifier: 2014-10-019
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (1)

Thermo-radio-chemotherapy arm

EXPERIMENTAL

Hyperthermia with concurrent chemo-radiation therapy

Radiation: Hyperthermia with concurrent chemo-radiation therapy

Interventions

Hyperthermia with concurrent chemo-radiation therapy RADIATION

Thermo-radio-chemotherapy arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Extrapelvic metastasis
• Previous pelvic irradiation
• Current status of pregnant or breast feeding
• Confirmed other malignancy within two years except thyroid cancer

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Results Point of Contact

• Title: Professor
• Organization: Samsung Medical Center

hee.ro.park@gmail.com

82-2-3410-2612

Study Officials

• Hee Chul Park, Professor

  Samsung Medical Center, Sungkyunkwan University School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocate Professor

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 14, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 1, 2019
• Results First Posted: November 1, 2019

Record last verified: 2019-10

Locations

KR (1)