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

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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

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date March 19, 2019
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Disease-free survival [ Time Frame: 3 years ]
    The rates of patients who survive without recurrence
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • Disease-free survival [ Time Frame: 3 years ]
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Radiotherapy-related complications [ Time Frame: 2 years ]
    Complications according to the CTCAE 4.0
  • 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.
  • Tumor response rate [ Time Frame: 2 years ]
    Amount of tumor regression after surgery according to the guideline including Mandard or Dworak
  • Postoperative complications [ Time Frame: 2 years ]
    Complications after surgery
  • Peripheral neuropathy [ Time Frame: 3 years ]
    Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • Radiotherapy-related complications [ Time Frame: 2 years ]
  • 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.
  • Postoperative complications [ Time Frame: 2 years ]
  • Peripheral neuropathy [ Time Frame: 3 years ]
    Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy
Official Title  ICMJE KCSP Trial of cONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After neoadjUvant Concurrent chemoraDiothErapy: A Multicenter, Randomized Controlled Trial (KONCLUDE Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE Drug: Chemotherapy
5-FU, Leucovorine, and Oxaliplatin (FOLFOX regimen)
Study Arms  ICMJE
  • Active Comparator: Adjuvant chemotherapy
    After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.
    Intervention: Drug: Chemotherapy
  • Experimental: Consolidation chemotherapy
    After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.
    Intervention: Drug: Chemotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2016)
358
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2016)
316
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Suk-Hwan Lee, MD, PhD +82-440-7044 leeshdr@gmail.com
Contact: Chang Woo Kim, MD +82-440-6222 kcwgkim@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02843191
Other Study ID Numbers  ICMJE KSCP2016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Suk-Hwan Lee, Kyung Hee University Hospital at Gangdong
Study Sponsor  ICMJE Kyung Hee University Hospital at Gangdong
Collaborators  ICMJE Korean Society of ColoProctology
Investigators  ICMJE
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
PRS Account Kyung Hee University Hospital at Gangdong
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP