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Completed

NCT Number: NCT03365765

mFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer

This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6; another group will use mFOLFOX6 combined with apatinib. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • signed informed consent form;
  • confirmed as colorectal cancer by pathology, and the stage is IIIB /IIIC according to the NCCN guidelines;
  • patients with primary colorectal cancer;
  • radical resection of colon cancer (CME) or radical resection of rectal cancer (TME) has done;
  • 3~4 weeks after radical resection ;
  • patients did not receive any radiotherapy and chemotherapy before operation

Exclusion criteria

  • emergency operation for colorectal cancer patients;
  • the situation after operation can not tolerance for systemic adjuvant chemotherapy (hemoglobin <95g/L, white blood cell <3 * 109/L, granulocyte <1.5 * 109/L and platelet <75 * 109/L, bilirubin>2.5N, alanine aminotransferase >2.5N, alkaline phosphatase >2.5N, urea nitrogen >2.5N, creatinine >2.5N, proteinuria, hematuria, temperature of >38 degree);
  • serious diseases such as cardiac insufficiency, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases;
  • patients participated in other clinical trials at the same time;
  • pregnant or perinatal women;
  • combined with other malignant tumors;
  • a history of neuropsychiatric disorders;
  • patients have used anti angiogenesis targeted drugs (such as bevacizumab, cetuximab);
  • patients had a history of severe trauma within 4 weeks before admission;
  • allergic to chemotherapy drugs or apatinib;
  • active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension

Treatment and study plan

apatinib

Drug

Apatinib tablet

Other names: YN968D1

Oxaliplatin

Drug

Oxaliplatin Intravenous

Other names: Eloxatin

5-fluorouracil

Drug

5-fluorouracil Intravenous

Other names: Adrucil, Carac, Efudex, Efudix

Primary outcomes

  1. disease-free survival

    Time frame: 5 years

    observe the recurrence of colorectal cancer after operation

Secondary outcomes

  1. overall survival

    Time frame: 5 years

    observe the postoperative survival rate in patients with stage IIIB and IIIC colorectal cancer

  2. incidence of adverse reactions after chemotherapy

    Time frame: one year

    observe the adverse reaction of apatinib or combined chemotherapy using apatinib

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

Exploratory Study on the Efficacy and the Safety of mFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2017
Registry last updated
Feb 14, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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