A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis

NCT01978249 | Terminated

• 1 other identifier: 4-2013-0277
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 12

Brief Summary

Short description for lay public, include brief statement of the study hypothesis

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Primary tumor resection; Chemotherapy; Overall survival; Quality of life

Outcome Measures

Primary Outcomes (1)

• Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection

  Comparison of the overall survival between patients who underwent primary tumor resection followed by chemotherapy and patients who received chemotherapy without primary tumor resection in stage IV colorectal cancer patients with unresectable metastasis.

  2 years after allocation

Secondary Outcomes (1)

• Analysis of primary tumor related complications in the chemotherapy group and postoperative complications in the primary tumor resection followed by the chemotherapy group.

  2 years after allocation

Other Outcomes (1)

• To compare the quality of life between the two groups using the Korean version of EORTC QLQ (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)-C30.

  2 years after allocation

Study Arms (2)

Chemotherapy first without primary tumor resection

EXPERIMENTAL

Patients will receive chemotherapy first without primary tumor resection.

Procedure: Systemic chemotherapy

Primary tumor resection followed by chemotherapy

ACTIVE COMPARATOR

Patients will receive primary tumor resection followed by chemotherapy.

Procedure: primary tumor resection (PTR)

Interventions

Systemic chemotherapy PROCEDURE

Chemotherapy first without primary tumor resection

primary tumor resection (PTR) PROCEDURE

primary tumor resection (PTR) using open or laparoscopy or robotic surgery

Primary tumor resection followed by chemotherapy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age : between 20 and 90 years old
• Histologically confirmed adenocarcinoma of the colon or the upper rectum
• Patients with resectable primary colon or upper rectal cancer and unresectable metastatic lesions.
• Patients with no primary cancer related symptoms.
• ECOG performance status of 0 - 2
• Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
• ASA score of \< 3
• An informed consent form has been signed by the patient.

You may not qualify if:

• The patient received adjuvant chemotherapy within the past 6 months.
• The patient received chemotherapy for metastatic colon cancer.
• The patient was planning to have curative surgery for the metastatic lesions.
• The primary cancer is unresectable.
• Patients with peritoneal carcinomatosis.
• Patients with mid and low rectal cancer (\< 10cm)
• Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
• ASA score of \> 4
• The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate.
• Patients with an active infection, which need antibiotic therapy, during the randomization period.
• Pregnant or breastfeeding women
• Patients who were enrolled in another clinical trial during the time of enrollment (within the 28 day randomization period).
• Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (12)

University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Location

National Cancer Center

Ilsan, Gyeonggi-do, South Korea

Location

Gachon University, Gil Hospital

Incheon, Gyeonggi-do, South Korea

Location

Seoul National University, Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Yeongnam University Hospital

Daegu, Gyeongsang-do, South Korea

Location

Wonkwang University Hospital

Iksan, Jeollabukdo, South Korea

Location

Chonnam National University Hospital

Gwangju, Jeonlla Nam-do, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Department of Surgery, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Yonsei University, Gangnam Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• Kim CW, Baek JH, Choi GS, Yu CS, Kang SB, Park WC, Lee BH, Kim HR, Oh JH, Kim JH, Jeong SY, Ahn JB, Baik SH. The role of primary tumor resection in colorectal cancer patients with asymptomatic, synchronous unresectable metastasis: Study protocol for a randomized controlled trial. Trials. 2016 Jan 19;17:34. doi: 10.1186/s13063-016-1164-0.

  PMID: 26782254 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

KR (12)