CONVERT: Neoadjuvant Chemotherapy Alone Versus Preoperative Chemoradiation for Locally Advanced Rectal Cancer Patients

Summary

Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term toxicities. More importantly, it has not been confirmed that neoadjuvant radiotherapy could improve overall survival. The purpose of this study is to compare the effects of chemotherapy alone using a combination regimen known as XELOX (capecitabine and oxaliplatin ) and selective use of the standard treatment to the standard treatment of chemotherapy and radiation.

Conditions

• Rectal Neoplasms

Interventions

DRUG

Oxaliplatin

130 mg/m² iv drip over 2 hours on day 1, repeated every 21 days.

DRUG

capecitabine

825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week. 1000 mg/m² po twice daily on days 1- 14 repeated every 21 days in Group A and adjuvant chemotherapy in Group B.

RADIATION

Radiation

The total dosage was 46Gy consisted of 23 fractions of 2 Gy to clinical target volume without a boost dose and with the boost 4 Gy consisted of 2 fractions of 2 Gy to gross tumor volume by IMRT or 3D-CRT.

Sponsors & Collaborators

• Shantou Central Hospital

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• Meizhou People's Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Affiliated Cancer Hospital of Shantou University Medical College

  collaborator OTHER

• Hubei Cancer Hospital

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Longyan City First Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Jiangmen Central Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The Third Affiliated Hospital of Kunming Medical College.

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Peirong Ding, MD, Ph D · Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-13

Primary Completion

2021-03-17

Completion

2024-03-31

Countries

• China

Study Locations