NCT02031939

Brief Summary

Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
556

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

6.9 years

First QC Date

December 30, 2013

Last Update Submit

August 23, 2023

Conditions

Advanced Rectal Cancer

Keywords

Rectal cancerneoadjuvant chemoradiotherapyoptimization

Outcome Measures

Primary Outcomes (1)

  • overall survival

    5 years

Secondary Outcomes (3)

  • disease free survival

    3 years

  • Disease free survival

    5 years

  • Respond rate

    One week after surgery

Study Arms (2)

Standard chemoradiotherapy

ACTIVE COMPARATOR

Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy )

Radiation: standard chemoradiotherapy

induction and gap chemotherapy

EXPERIMENTAL

induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + 2 cycles of chemoradiotherapy (Capecitabine 2000mg/m2 +oxaliplatine 100mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2)

Drug: Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)

Interventions

Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)DRUG

All rectal cancer patients in this group will receive induction, gap chemotherapy (capecitabine combined with oxaliplatin) alone with chemoradiotherapy (capecitabine combine with oxaliplatin) before surgery.

induction and gap chemotherapy
standard chemoradiotherapyRADIATION

All rectal patients in this group will receive standard radiotherapy and surgical resection.

Standard chemoradiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathological confirmed rectal cancer
  • Clinical stage T3-4 or T any N1
  • No metastasis
  • Distance of tumor is no more than 10cm from anal verge
  • No previous radiotherapy
  • Age ranged from 18 to 70
  • Eastern Cooperative Oncology Group score system 0-1

You may not qualify if:

  • Clinical stage T1-2 N0
  • Distance metastasis
  • Multiple primary tumor
  • Cachexy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Induction ChemotherapyChemoradiotherapyOxaliplatin

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsRemission InductionCombined Modality TherapyRadiotherapyCoordination ComplexesOrganic Chemicals

Study Officials

  • Zhen-Hai Lu, Prof.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

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
Pofessor

Study Record Dates

First Submitted

December 30, 2013

First Posted

January 9, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2025

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

CN(1)