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

NCT02843191 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: KSCP2016
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 14

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.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; Consolidation Chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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)

  2 years

• Disease-free survival

  The rates of patients who survive without recurrence

  3 years

Secondary Outcomes (5)

• Radiotherapy-related complications

  2 years

• R0 resection

  2 years

• Tumor response rate

  2 years

• Postoperative complications

  2 years

• Peripheral neuropathy

  3 years

Study Arms (2)

Adjuvant chemotherapy

ACTIVE COMPARATOR

After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.

Drug: Chemotherapy

Consolidation chemotherapy

EXPERIMENTAL

After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)

Adjuvant chemotherapy; Consolidation chemotherapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead
• Korean Society of ColoProctology: collaborator
• Pharmbio Korea Inc.: collaborator
• Samjin Pharmaceutical Co., Ltd.: collaborator
• Boryung Pharmaceutical Co., Ltd: collaborator
• JW Pharmaceutical: collaborator

Study Sites (14)

Inje University Busan Paik hospital

Busan, 47392, South Korea

Location

Soonchunhyang University Cheonan Hospital

Cheonan, 31151, South Korea

Location

Chuncheon Sacred Heart Hospital, Hallym University College of Medicine

Chuncheon, 24253, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

Location

Wonkwang University Hospital

Iksan, 54538, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, 01757, South Korea

Location

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, 06273, South Korea

Location

Seoul St. Mary's Hospital, The Catholic University College of Medicine

Seoul, 06591, South Korea

Location

Ajou University School of Medicine

Suwon, 16499, South Korea

Location

Uijeongbu St. Mary's Hospital, The Catholic University College of Medicine

Uijeongbu-si, 11765, South Korea

Location

Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine

Wŏnju, 26426, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

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MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Suk-Hwan Lee, MD, PhD

  892 Dongnam-ro, Gangdong-gu, Seoul, Korea. Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

• Chang Woo Kim, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 25, 2016
• Study Start: December 7, 2016
• Primary Completion: July 15, 2023
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (14)