Multicenter, Prospective, RCT：Investigation of Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer.

Summary

At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy (NCRT) followed by radical surgery has become the standard of care for the locally advanced mid/low rectal cancer, having been proved to substantially improve the local control of the disease, whereas not being able to improve the long-term survival. According to present clinical practice guidelines, all patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer are recommended to undergo the preoperative long-term radiotherapy with concurrent 5FU based chemotherapy, followed by the radical resection of the tumor. After surgery, adjuvant chemotherapy (ACT) is recommended for all these patients without considering the postoperative pathological results. Recently, however, some authors proposed that different strategy of combined modality therapy should be applied in different patients according to their risk of relapse, instead of using the uniform NCRT strategy. In this research, on the basis of investigator's previous clinical practice and researches, investigators plan to stratify the patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer into several subgroups according to tumor stages and the risk of relapse. Different therapeutic strategy will be applied in different groups, at the aim of improving the overall therapeutic effects, as well as reducing the treatment adverse effects.

This research consists of four trials.

Conditions

• Rectal Cancer, Adenocarcinoma
• Neoadjuvant Chemoradiation

Interventions

OTHER

non-NCRT

without the preoperative concurrent chemoradiothearpy (no neoadjuvant chemoradiation)

OTHER

NCRT

the preoperative concurrent chemoradiothearpy (neoadjuvant chemoradiation)

DRUG

capecitabine with oxaliplatin

combined chemotherapy with capecitabine with oxaliplatin

DRUG

capecitabine

single-agent chemotherapy with capecitabine

PROCEDURE

TEM

transanal endoscopic microsurgery (TEM) excision of the lesion

PROCEDURE

radical resection

radical resection of rectal cancer

Sponsors & Collaborators

• Beijing Hospital

  collaborator OTHER_GOV

• Beijing Chao Yang Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Geneplus-Beijing Co. Ltd.

  collaborator INDUSTRY

• Peking Union Medical College Hospital

  lead OTHER

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

2017-02-28

Primary Completion

2020-12-31

Completion

2021-12-31