Back to resultsConsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy
Primary Purpose
Rectal Cancer
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Consolidation Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of mid or low rectum
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)
- ECOG performance status of 0-2
- ASA grade ≤ 3
- An informed consent has been signed by the patient
Exclusion Criteria:
- Upper rectal cancer
- Clinical stage T1or2N0 on MRI
- Clinical stage T4Nany on MRI
- Clinical stage TanyNanyM1 by image or histology
- The patient received chemotherapy or radiotherapy during the past 6 months
- The patient received any therapy for colorectal cancer or another malignancy during the past 5 years
- The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy
- Pregnant of breastfeeding women
- The patient who participate in another clinical trial, or receives any drug for the trial
- Uncontrolled peripheral neuropathy (more than grade 2)
- Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess
- Active gastrointestinal bleeding
- Patients with an active infection, which needs antibiotic therapy, during the randomization period
Sites / Locations
- Inje University Busan Paik hospital
- Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
- Keimyung University Dongsan Medical CenterRecruiting
- Chungnam National University HospitalRecruiting
- Chonnam National University Hwasun HospitalRecruiting
- Wonkwang University HospitalRecruiting
- Inje University Sanggye Paik HospitalRecruiting
- Gangnam Severance Hospital, Yonsei University College of Medicine
- Seoul St. Mary's Hospital, The Catholic University College of MedicineRecruiting
- Ajou University School of MedicineRecruiting
- Uijeongbu St. Mary's Hospital, The Catholic University College of MedicineRecruiting
- Wonju Severance Christian Hospital, Yonsei University Wonju College of MedicineRecruiting
- Pusan National University Yangsan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Adjuvant chemotherapy
Consolidation chemotherapy
Arm Description
After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.
After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.
Outcomes
Primary Outcome Measures
Disease-free survival
The rates of patients who survive without recurrence
Pathologic complete response
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
Radiotherapy-related complications
Complications according to the CTCAE 4.0
R0 resection
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
Amount of tumor regression after surgery according to the guideline including Mandard or Dworak
Postoperative complications
Complications after surgery
Peripheral neuropathy
Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.
Full Information
NCT ID
NCT02843191
First Posted
July 19, 2016
Last Updated
March 12, 2023
Sponsor
Kyung Hee University Hospital at Gangdong
Collaborators
Korean Society of ColoProctology
1. Study Identification
Unique Protocol Identification Number
NCT02843191
Brief Title
Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2016 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyung Hee University Hospital at Gangdong
Collaborators
Korean Society of ColoProctology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal Cancer, Consolidation Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adjuvant chemotherapy
Arm Type
Active Comparator
Arm Description
After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.
Arm Title
Consolidation chemotherapy
Arm Type
Experimental
Arm Description
After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)
Primary Outcome Measure Information:
Title
Disease-free survival
Description
The rates of patients who survive without recurrence
Time Frame
3 years
Title
Pathologic complete response
Description
Pathologic complete response is defined as no residual tumor on the surgical specimen after chemoradiotherapy. (i.e. Mandard grade 1 or Dworak grade 4)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Radiotherapy-related complications
Description
Complications according to the CTCAE 4.0
Time Frame
2 years
Title
R0 resection
Description
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.
Time Frame
2 years
Title
Tumor response rate
Description
Amount of tumor regression after surgery according to the guideline including Mandard or Dworak
Time Frame
2 years
Title
Postoperative complications
Description
Complications after surgery
Time Frame
2 years
Title
Peripheral neuropathy
Description
Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of mid or low rectum
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)
ECOG performance status of 0-2
ASA grade ≤ 3
An informed consent has been signed by the patient
Exclusion Criteria:
Upper rectal cancer
Clinical stage T1or2N0 on MRI
Clinical stage T4Nany on MRI
Clinical stage TanyNanyM1 by image or histology
The patient received chemotherapy or radiotherapy during the past 6 months
The patient received any therapy for colorectal cancer or another malignancy during the past 5 years
The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy
Pregnant of breastfeeding women
The patient who participate in another clinical trial, or receives any drug for the trial
Uncontrolled peripheral neuropathy (more than grade 2)
Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess
Active gastrointestinal bleeding
Patients with an active infection, which needs antibiotic therapy, during the randomization period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suk-Hwan Lee, MD, PhD
Phone
+82-2-440-7044
Email
leeshdr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Woo Kim, MD, PhD
Phone
+82-31-219-4451
Email
kcwgkim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suk-Hwan Lee, MD, PhD
Organizational Affiliation
892 Dongnam-ro, Gangdong-gu, Seoul, Korea. Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang Woo Kim, MD, PhD
Organizational Affiliation
164 Worldcup-ro, Yeongtong-gu, Suwon, Korea. Ajou University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Inje University Busan Paik hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
City
Chuncheon
ZIP/Postal Code
24253
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woon Kyung Jeong, MD
Phone
82-10-2535-8440
Email
shinycloud@daum.net
First Name & Middle Initial & Last Name & Degree
Seong Kyu Baek, MD
Phone
82-10-8745-2317
Email
sgbeak@dsmc.or.kr
First Name & Middle Initial & Last Name & Degree
Seong Kyu Baek, MD
First Name & Middle Initial & Last Name & Degree
Woon Kyung Jeong, MD
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Soo Kim, MD
Phone
82-10-8887-7562
Email
jskim7562@gmail.com
First Name & Middle Initial & Last Name & Degree
Ji Yeon Kim, MD
Phone
82-10-9414-6909
Email
jkim@cnu.ac.kr
First Name & Middle Initial & Last Name & Degree
Ji Yeon Kim, MD
First Name & Middle Initial & Last Name & Degree
Jin Soo Kim, MD
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Young Lee, MD
Phone
82-10-6779-6005
Email
lsy9983@naver.com
First Name & Middle Initial & Last Name & Degree
Hyeong Rok Kim, MD
Phone
82-10-7172-6496
Email
drkhr@jnu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyeong Rok Kim, MD
First Name & Middle Initial & Last Name & Degree
Soo Young Lee, MD
Facility Name
Wonkwang University Hospital
City
Iksan
ZIP/Postal Code
54538
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Cheol Park, MD
Phone
82-10-2926-5977
Email
parkwc@wonkwang.ac.kr
First Name & Middle Initial & Last Name & Degree
Won Cheol Park, MD
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
ZIP/Postal Code
01757
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung-Noe Bae, MD
Phone
82-10-6215-6566
Email
bnbae1@naver.com
First Name & Middle Initial & Last Name & Degree
Byung-Noe Bae, MD
Facility Name
Gangnam Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul St. Mary's Hospital, The Catholic University College of Medicine
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon Suk Lee, MD
Phone
82-10-3760-0765
Email
yslee@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Yoon Suk Lee, MD
Facility Name
Ajou University School of Medicine
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Woo Kim, MD, PhD
Phone
82-31-219-4451
Email
kcwgkim@gmail.com
First Name & Middle Initial & Last Name & Degree
Jun Sang Shin, MD
Phone
82-31-219-7500
Email
jsshin1980@gmail.com
First Name & Middle Initial & Last Name & Degree
Chang Woo Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jun Sang Shin, MD
Facility Name
Uijeongbu St. Mary's Hospital, The Catholic University College of Medicine
City
Uijeongbu
ZIP/Postal Code
11765
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Im Lee, MD
Phone
82-10-8550-0958
Email
lji96@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Seong-Taek Oh, MD
Phone
82-10-9191-1923
Email
stoh@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Seong-Taek Oh, MD
First Name & Middle Initial & Last Name & Degree
Jae-Im Lee, MD
Facility Name
Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine
City
Wonju
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ik Yong Kim, MD
Phone
82-10-4644-5508
Email
iykim@yonsei.ac.kr
First Name & Middle Initial & Last Name & Degree
Ik Yong Kim, MD
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyung Mo Son, MD
Phone
82-10-7523-8056
Email
skm171@naver.com
First Name & Middle Initial & Last Name & Degree
Gyung Mo Son, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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PubMed Identifier
29739356
Citation
Kim CW, Kang BM, Kim IY, Kim JY, Park SJ, Park WC, Bae KB, Bae BN, Baek SK, Baik SH, Son GM, Lee YS, Lee SH. Korean Society of Coloproctology (KSCP) trial of cONsolidation Chemotherapy for Locally advanced mid or low rectal cancer after neoadjUvant concurrent chemoraDiothErapy: a multicenter, randomized controlled trial (KONCLUDE). BMC Cancer. 2018 May 8;18(1):538. doi: 10.1186/s12885-018-4466-7.
Results Reference
derived
Learn more about this trial
Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy
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