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NCT Number: NCT02843191

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Inje University Busan Paik hospital, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

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

Primary outcomes

  1. 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. Disease-free survival

    Time frame: 3 years

    The rates of patients who survive without recurrence

Secondary outcomes

  1. Radiotherapy-related complications

    Time frame: 2 years

    Complications according to the CTCAE 4.0

  2. 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.

  3. Tumor response rate

    Time frame: 2 years

    Amount of tumor regression after surgery according to the guideline including Mandard or Dworak

  4. Postoperative complications

    Time frame: 2 years

    Complications after surgery

  5. Peripheral neuropathy

    Time frame: 3 years

    Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.

Sponsors and collaborators

Lead sponsor

Kyung Hee University Hospital at Gangdong

Other

Collaborators

  • Boryung Pharmaceutical Co., Ltd
  • JW Pharmaceutical
  • Korean Society of ColoProctology
  • Pharmbio Korea Inc.
  • Samjin Pharmaceutical Co., Ltd.

Registry information

Official study title

KCSP Trial of CONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After NeoadjUvant Concurrent ChemoraDiothErapy: a Multicenter, Randomized Controlled Trial (KONCLUDE)

Important dates

Study start
2016
Primary completion
2023
Study completion
2026
First posted
Jul 25, 2016
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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