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

March 12, 2023 updated by: Suk-Hwan Lee, Kyung Hee University Hospital at Gangdong

KCSP Trial of cONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After neoadjUvant Concurrent chemoraDiothErapy: A Multicenter, Randomized Controlled Trial (KONCLUDE Trial)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

358

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chang Woo Kim, MD, PhD
  • Phone Number: +82-31-219-4451
  • Email: kcwgkim@gmail.com

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Active, not recruiting
        • Inje University Busan Paik Hospital
      • Chuncheon, Korea, Republic of, 24253
        • Active, not recruiting
        • Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
      • Daegu, Korea, Republic of, 41931
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seong Kyu Baek, MD
        • Sub-Investigator:
          • Woon Kyung Jeong, MD
      • Daejeon, Korea, Republic of, 35015
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ji Yeon Kim, MD
        • Sub-Investigator:
          • Jin Soo Kim, MD
      • Hwasun, Korea, Republic of, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hyeong Rok Kim, MD
        • Sub-Investigator:
          • Soo Young Lee, MD
      • Iksan, Korea, Republic of, 54538
        • Recruiting
        • Wonkwang University Hospital
        • Contact:
        • Principal Investigator:
          • Won Cheol Park, MD
      • Seoul, Korea, Republic of, 01757
        • Recruiting
        • Inje University Sanggye Paik Hospital
        • Contact:
        • Principal Investigator:
          • Byung-Noe Bae, MD
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Seoul St. Mary's Hospital, The Catholic University College of Medicine
        • Contact:
        • Principal Investigator:
          • Yoon Suk Lee, MD
      • Seoul, Korea, Republic of, 06273
        • Active, not recruiting
        • Gangnam Severance Hospital, Yonsei University College of Medicine
      • Suwon, Korea, Republic of, 16499
        • Recruiting
        • Ajou University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chang Woo Kim, MD, PhD
        • Sub-Investigator:
          • Jun Sang Shin, MD
      • Uijeongbu, Korea, Republic of, 11765
        • Recruiting
        • Uijeongbu St. Mary's Hospital, The Catholic University College of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seong-Taek Oh, MD
        • Sub-Investigator:
          • Jae-Im Lee, MD
      • Wonju, Korea, Republic of, 26426
        • Recruiting
        • Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine
        • Contact:
        • Principal Investigator:
          • Ik Yong Kim, MD
      • Yangsan, Korea, Republic of, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
        • Principal Investigator:
          • Gyung Mo Son, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 years
The rates of patients who survive without recurrence
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)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiotherapy-related complications
Time Frame: 2 years
Complications according to the CTCAE 4.0
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.
2 years
Tumor response rate
Time Frame: 2 years
Amount of tumor regression after surgery according to the guideline including Mandard or Dworak
2 years
Postoperative complications
Time Frame: 2 years
Complications after surgery
2 years
Peripheral neuropathy
Time Frame: 3 years
Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyung Hee University Hospital at Gangdong

Collaborators

Korean Society of ColoProctology

Investigators

  • 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, PhD, 164 Worldcup-ro, Yeongtong-gu, Suwon, Korea. Ajou University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSCP2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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