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Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843191
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Korean Society of ColoProctology
Information provided by (Responsible Party):
Suk-Hwan Lee, Kyung Hee University Hospital at Gangdong

Brief Summary:
This trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Chemotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: KCSP Trial of cONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After neoadjUvant Concurrent chemoraDiothErapy: A Multicenter, Randomized Controlled Trial (KONCLUDE Trial)
Study Start Date : December 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Active Comparator: Adjuvant chemotherapy
After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.
Drug: Chemotherapy
5-FU, Leucovorine, and Oxaliplatin (FOLFOX regimen)

Experimental: Consolidation chemotherapy
After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.
Drug: Chemotherapy
5-FU, Leucovorine, and Oxaliplatin (FOLFOX regimen)




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years ]
    The rates of patients who survive without recurrence

  2. Pathologic complete response [ Time Frame: 2 years ]
    Pathologic complete response is defined as no residual tumor on the surgical specimen after chemoradiotherapy. (i.e. Mandard grade 1 or Dworak grade 4)


Secondary Outcome Measures :
  1. Radiotherapy-related complications [ Time Frame: 2 years ]
    Complications according to the CTCAE 4.0

  2. R0 resection [ Time Frame: 2 years ]
    R0 resection is defined as resection without remnant tumor, whereas R1 resection as microscopic residual tumor and R2 resection as gross residual tumor. R0 resection will be proven histologically as no resection margin involvement of tumor.

  3. Tumor response rate [ Time Frame: 2 years ]
    Amount of tumor regression after surgery according to the guideline including Mandard or Dworak

  4. Postoperative complications [ Time Frame: 2 years ]
    Complications after surgery

  5. Peripheral neuropathy [ Time Frame: 3 years ]
    Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of mid or low rectum
  2. Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)

    • Clinical stage T1-3N1or2 on MRI
    • Clinical stage cT3N0 (or depth of perirectal invasion by tumor >5mm on MRI)
    • Suspicious of circumferential invasion on MRI (or circumferential margin <1mm)
  3. ECOG performance status of 0-2
  4. ASA grade ≤ 3
  5. An informed consent has been signed by the patient

Exclusion Criteria:

  1. Upper rectal cancer
  2. Clinical stage T1or2N0 on MRI
  3. Clinical stage T4Nany on MRI
  4. Clinical stage TanyNanyM1 by image or histology
  5. The patient received chemotherapy or radiotherapy during the past 6 months
  6. The patient received any therapy for colorectal cancer or another malignancy during the past 5 years
  7. The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy
  8. Pregnant of breastfeeding women
  9. The patient who participate in another clinical trial, or receives any drug for the trial
  10. Uncontrolled peripheral neuropathy (more than grade 2)
  11. Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess
  12. Active gastrointestinal bleeding
  13. Patients with an active infection, which needs antibiotic therapy, during the randomization period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843191


Contacts
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Contact: Suk-Hwan Lee, MD, PhD +82-440-7044 leeshdr@gmail.com
Contact: Chang Woo Kim, MD +82-440-6222 kcwgkim@gmail.com

Locations
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Korea, Republic of
Inje University Busan Paik hospital Recruiting
Busan, Korea, Republic of, 47392
Contact: Min Sung An, MD    82-10-2863-8283    gsams@paik.ac.kr   
Contact: Ki Beom Bae, MD    82-10-4557-5643    bkbsur@daum.net   
Principal Investigator: Ki Beom Bae, MD         
Sub-Investigator: Min Sung An, MD         
Chuncheon Sacred Heart Hospital, Hallym University College of Medicine Recruiting
Chuncheon, Korea, Republic of, 24253
Contact: Byung Mo Kang, MD    82-10-8586-6963    kbm0728@yahoo.co.kr   
Principal Investigator: Byung Mo Kang, MD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 41931
Contact: Woon Kyung Jeong, MD    82-10-2535-8440    shinycloud@daum.net   
Contact: Seong Kyu Baek, MD    82-10-8745-2317    sgbeak@dsmc.or.kr   
Principal Investigator: Seong Kyu Baek, MD         
Sub-Investigator: Woon Kyung Jeong, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 35015
Contact: Jin Soo Kim, MD    82-10-8887-7562    jskim7562@gmail.com   
Contact: Ji Yeon Kim, MD    82-10-9414-6909    jkim@cnu.ac.kr   
Principal Investigator: Ji Yeon Kim, MD         
Sub-Investigator: Jin Soo Kim, MD         
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Korea, Republic of, 58128
Contact: Soo Young Lee, MD    82-10-6779-6005    lsy9983@naver.com   
Contact: Hyeong Rok Kim, MD    82-10-7172-6496    drkhr@jnu.ac.kr   
Principal Investigator: Hyeong Rok Kim, MD         
Sub-Investigator: Soo Young Lee, MD         
Wonkwang University Hospital Recruiting
Iksan, Korea, Republic of, 54538
Contact: Won Cheol Park, MD    82-10-2926-5977    parkwc@wonkwang.ac.kr   
Principal Investigator: Won Cheol Park, MD         
Inje University Sanggye Paik Hospital Recruiting
Seoul, Korea, Republic of, 01757
Contact: Byung-Noe Bae, MD    82-10-6215-6566    bnbae1@naver.com   
Principal Investigator: Byung-Noe Bae, MD         
Gangnam Severance Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 06273
Contact: Seung Hyuk Baik, MD    82-10-2443-7275    whitenoja@yuhs.ac   
Principal Investigator: Seung Hyuk Baik, MD         
Seoul St. Mary's Hospital, The Catholic University College of Medicine Recruiting
Seoul, Korea, Republic of, 06591
Contact: Yoon Suk Lee, MD    82-10-3760-0765    yslee@catholic.ac.kr   
Principal Investigator: Yoon Suk Lee, MD         
Uijeongbu St. Mary's Hospital, The Catholic University College of Medicine Recruiting
Uijeongbu, Korea, Republic of, 11765
Contact: Jae-Im Lee, MD    82-10-8550-0958    lji96@catholic.ac.kr   
Contact: Seong-Taek Oh, MD    82-10-9191-1923    stoh@catholic.ac.kr   
Principal Investigator: Seong-Taek Oh, MD         
Sub-Investigator: Jae-Im Lee, MD         
Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine Recruiting
Wonju, Korea, Republic of, 26426
Contact: Ik Yong Kim, MD    82-10-4644-5508    iykim@yonsei.ac.kr   
Principal Investigator: Ik Yong Kim, MD         
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of, 50612
Contact: Gyung Mo Son, MD    82-10-7523-8056    skm171@naver.com   
Principal Investigator: Gyung Mo Son, MD         
Sponsors and Collaborators
Kyung Hee University Hospital at Gangdong
Korean Society of ColoProctology
Investigators
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Principal Investigator: Suk-Hwan Lee, MD, PhD 892 Dongnam-ro, Gangdong-gu, Seoul, Korea. Kyung Hee University Hospital at Gangdong
Study Director: Chang Woo Kim, MD 892 Dongnam-ro, Gangdong-gu, Seoul, Korea. Kyung Hee University Hospital at Gangdong
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Suk-Hwan Lee, Professor, Kyung Hee University Hospital at Gangdong
ClinicalTrials.gov Identifier: NCT02843191    
Other Study ID Numbers: KSCP2016
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Suk-Hwan Lee, Kyung Hee University Hospital at Gangdong:
Rectal Cancer
Consolidation Chemotherapy
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases