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)

Chang Woo Kim, Byung Mo Kang, Ik Yong Kim, Ji Yeon Kim, Sun Jin Park, Won Cheol Park, Ki Beom Bae, Byung Noe Bae, Seong Kyu Baek, Seung Hyuk Baik, Gyung Mo Son, Yoon Suk Lee, Suk Hwan Lee

Research output: Contribution to journalArticle

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Abstract

Background: Neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision (TME) has been a standard treatment option for locally advanced rectal cancer with improved local control. However, systemic recurrence despite neoadjuvant CRT remained unchanged. The only significant prognostic factor proven to be important was pathologic complete response (pCR) after neoadjuvant CRT. Several efforts have been tried to improve survival of patients who treated with neoadjuvant CRT and to achieve more pCR including adding cytotoxic chemotherapeutic agents, chronologic modification of chemotherapy schedule or adding chemotherapy during the perioperative period. Consolidation chemotherapy is adding several cycles of chemotherapy between neoadjuvant CRT and TME. It could increase pCR rate, subsequently could show better oncologic outcomes. Methods: Patients with advanced mid or low rectal cancer who received neoadjuvant CRT will be included after screening. They will be randomized and assigned to undergo TME followed by 8cycles of adjuvant chemotherapy (control arm) or receive 3cycles of consolidation chemotherapy before TME, and receive 5cycles of adjuvant chemotherapy (experimental arm). The primary endpoints are pCR and 3-year disease-free survival (DFS), and the secondary endpoints are radiotherapy-related complications, R0 resection rate, tumor response rate, surgery-related morbidity, and peripheral neuropathy at 3year after the surgery. The authors hypothesize that the experimental arm would show a 15% improvement in pCR (15 to 30%) and in 3-year DFS (65 to 80%), compared with the control arm. The accrual period is 2years and the follow-up period is 3years. Based on the superiority design, one-sided log-rank test with α-error of 0.025 and a power of 80% was conducted. Allowing for a drop-out rate of 10%, 358 patients (179 per arm) will need to be recruited. Patients will be followed up at every 3months for 2years and then every 6months for 3years after the last patient has been randomized. Discussion: KONCLUDE trial aims to investigate whether consolidation chemotherapy shows better pCR and 3-year DFS than adjuvant chemotherapy alone for the patients who received neoadjuvant CRT for locally advanced rectal cancer. This trial is expected to provide evidence to support clear treatment guidelines for patients with locally advanced rectal cancer. Trial registration: Clinicaltrials.gov NCT02843191(First posted on July 25, 2016).

Original languageEnglish
Article number538
JournalBMC cancer
Volume18
Issue number1
DOIs
Publication statusPublished - 2018 May 8

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Consolidation Chemotherapy
Chemoradiotherapy
Rectal Neoplasms
Randomized Controlled Trials
Adjuvant Chemotherapy
Disease-Free Survival
Drug Therapy
Perioperative Period
Cytotoxins
Peripheral Nervous System Diseases
Appointments and Schedules
Radiotherapy
Guidelines
Morbidity
Recurrence
Survival
Therapeutics

All Science Journal Classification (ASJC) codes

  • Genetics
  • Oncology
  • Cancer Research

Cite this

Kim, Chang Woo ; Kang, Byung Mo ; Kim, Ik Yong ; Kim, Ji Yeon ; Park, Sun Jin ; Park, Won Cheol ; Bae, Ki Beom ; Bae, Byung Noe ; Baek, Seong Kyu ; Baik, Seung Hyuk ; Son, Gyung Mo ; Lee, Yoon Suk ; Lee, Suk Hwan. / 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). In: BMC cancer. 2018 ; Vol. 18, No. 1.
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abstract = "Background: Neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision (TME) has been a standard treatment option for locally advanced rectal cancer with improved local control. However, systemic recurrence despite neoadjuvant CRT remained unchanged. The only significant prognostic factor proven to be important was pathologic complete response (pCR) after neoadjuvant CRT. Several efforts have been tried to improve survival of patients who treated with neoadjuvant CRT and to achieve more pCR including adding cytotoxic chemotherapeutic agents, chronologic modification of chemotherapy schedule or adding chemotherapy during the perioperative period. Consolidation chemotherapy is adding several cycles of chemotherapy between neoadjuvant CRT and TME. It could increase pCR rate, subsequently could show better oncologic outcomes. Methods: Patients with advanced mid or low rectal cancer who received neoadjuvant CRT will be included after screening. They will be randomized and assigned to undergo TME followed by 8cycles of adjuvant chemotherapy (control arm) or receive 3cycles of consolidation chemotherapy before TME, and receive 5cycles of adjuvant chemotherapy (experimental arm). The primary endpoints are pCR and 3-year disease-free survival (DFS), and the secondary endpoints are radiotherapy-related complications, R0 resection rate, tumor response rate, surgery-related morbidity, and peripheral neuropathy at 3year after the surgery. The authors hypothesize that the experimental arm would show a 15{\%} improvement in pCR (15 to 30{\%}) and in 3-year DFS (65 to 80{\%}), compared with the control arm. The accrual period is 2years and the follow-up period is 3years. Based on the superiority design, one-sided log-rank test with α-error of 0.025 and a power of 80{\%} was conducted. Allowing for a drop-out rate of 10{\%}, 358 patients (179 per arm) will need to be recruited. Patients will be followed up at every 3months for 2years and then every 6months for 3years after the last patient has been randomized. Discussion: KONCLUDE trial aims to investigate whether consolidation chemotherapy shows better pCR and 3-year DFS than adjuvant chemotherapy alone for the patients who received neoadjuvant CRT for locally advanced rectal cancer. This trial is expected to provide evidence to support clear treatment guidelines for patients with locally advanced rectal cancer. Trial registration: Clinicaltrials.gov NCT02843191(First posted on July 25, 2016).",
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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). / Kim, Chang Woo; Kang, Byung Mo; Kim, Ik Yong; Kim, Ji Yeon; Park, Sun Jin; Park, Won Cheol; Bae, Ki Beom; Bae, Byung Noe; Baek, Seong Kyu; Baik, Seung Hyuk; Son, Gyung Mo; Lee, Yoon Suk; Lee, Suk Hwan.

In: BMC cancer, Vol. 18, No. 1, 538, 08.05.2018.

Research output: Contribution to journalArticle

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T1 - Korean Society of Coloproctology (KSCP) trial of cONsolidation Chemotherapy for Locally advanced mid or low rectal cancer after neoadjUvant concurrent chemoraDiothErapy

T2 - A multicenter, randomized controlled trial (KONCLUDE)

AU - Kim, Chang Woo

AU - Kang, Byung Mo

AU - Kim, Ik Yong

AU - Kim, Ji Yeon

AU - Park, Sun Jin

AU - Park, Won Cheol

AU - Bae, Ki Beom

AU - Bae, Byung Noe

AU - Baek, Seong Kyu

AU - Baik, Seung Hyuk

AU - Son, Gyung Mo

AU - Lee, Yoon Suk

AU - Lee, Suk Hwan

PY - 2018/5/8

Y1 - 2018/5/8

N2 - Background: Neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision (TME) has been a standard treatment option for locally advanced rectal cancer with improved local control. However, systemic recurrence despite neoadjuvant CRT remained unchanged. The only significant prognostic factor proven to be important was pathologic complete response (pCR) after neoadjuvant CRT. Several efforts have been tried to improve survival of patients who treated with neoadjuvant CRT and to achieve more pCR including adding cytotoxic chemotherapeutic agents, chronologic modification of chemotherapy schedule or adding chemotherapy during the perioperative period. Consolidation chemotherapy is adding several cycles of chemotherapy between neoadjuvant CRT and TME. It could increase pCR rate, subsequently could show better oncologic outcomes. Methods: Patients with advanced mid or low rectal cancer who received neoadjuvant CRT will be included after screening. They will be randomized and assigned to undergo TME followed by 8cycles of adjuvant chemotherapy (control arm) or receive 3cycles of consolidation chemotherapy before TME, and receive 5cycles of adjuvant chemotherapy (experimental arm). The primary endpoints are pCR and 3-year disease-free survival (DFS), and the secondary endpoints are radiotherapy-related complications, R0 resection rate, tumor response rate, surgery-related morbidity, and peripheral neuropathy at 3year after the surgery. The authors hypothesize that the experimental arm would show a 15% improvement in pCR (15 to 30%) and in 3-year DFS (65 to 80%), compared with the control arm. The accrual period is 2years and the follow-up period is 3years. Based on the superiority design, one-sided log-rank test with α-error of 0.025 and a power of 80% was conducted. Allowing for a drop-out rate of 10%, 358 patients (179 per arm) will need to be recruited. Patients will be followed up at every 3months for 2years and then every 6months for 3years after the last patient has been randomized. Discussion: KONCLUDE trial aims to investigate whether consolidation chemotherapy shows better pCR and 3-year DFS than adjuvant chemotherapy alone for the patients who received neoadjuvant CRT for locally advanced rectal cancer. This trial is expected to provide evidence to support clear treatment guidelines for patients with locally advanced rectal cancer. Trial registration: Clinicaltrials.gov NCT02843191(First posted on July 25, 2016).

AB - Background: Neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision (TME) has been a standard treatment option for locally advanced rectal cancer with improved local control. However, systemic recurrence despite neoadjuvant CRT remained unchanged. The only significant prognostic factor proven to be important was pathologic complete response (pCR) after neoadjuvant CRT. Several efforts have been tried to improve survival of patients who treated with neoadjuvant CRT and to achieve more pCR including adding cytotoxic chemotherapeutic agents, chronologic modification of chemotherapy schedule or adding chemotherapy during the perioperative period. Consolidation chemotherapy is adding several cycles of chemotherapy between neoadjuvant CRT and TME. It could increase pCR rate, subsequently could show better oncologic outcomes. Methods: Patients with advanced mid or low rectal cancer who received neoadjuvant CRT will be included after screening. They will be randomized and assigned to undergo TME followed by 8cycles of adjuvant chemotherapy (control arm) or receive 3cycles of consolidation chemotherapy before TME, and receive 5cycles of adjuvant chemotherapy (experimental arm). The primary endpoints are pCR and 3-year disease-free survival (DFS), and the secondary endpoints are radiotherapy-related complications, R0 resection rate, tumor response rate, surgery-related morbidity, and peripheral neuropathy at 3year after the surgery. The authors hypothesize that the experimental arm would show a 15% improvement in pCR (15 to 30%) and in 3-year DFS (65 to 80%), compared with the control arm. The accrual period is 2years and the follow-up period is 3years. Based on the superiority design, one-sided log-rank test with α-error of 0.025 and a power of 80% was conducted. Allowing for a drop-out rate of 10%, 358 patients (179 per arm) will need to be recruited. Patients will be followed up at every 3months for 2years and then every 6months for 3years after the last patient has been randomized. Discussion: KONCLUDE trial aims to investigate whether consolidation chemotherapy shows better pCR and 3-year DFS than adjuvant chemotherapy alone for the patients who received neoadjuvant CRT for locally advanced rectal cancer. This trial is expected to provide evidence to support clear treatment guidelines for patients with locally advanced rectal cancer. Trial registration: Clinicaltrials.gov NCT02843191(First posted on July 25, 2016).

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