NCT01064999

Brief Summary

Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal cancer. Pathological complete response (pCR) is an important prognostic factor for local control and survival. A high intensity CRT increases not only the pCR rate, but also toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8 weeks after CRT.

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
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_2

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

February 5, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

February 5, 2010

Last Update Submit

March 12, 2012

Conditions

Rectal Cancer

Keywords

Neoadjuvant chemotherapylocally advanced rectal cancerintensity-modulated radiation therapypathological complete response

Outcome Measures

Primary Outcomes (2)

  • the rate of pathological complete response (pCR)

    within 14days after surgery

  • toxicity

    every week during radiotherapy

Secondary Outcomes (3)

  • local recurrence

    every half year after surgery

  • disease-free survival

    every half year after surgery

  • overall survival

    every half year after surgery

Study Arms (2)

High intensity group

EXPERIMENTAL

(RT 55Gy + CapOx) + a cycle of Xelox + Surgery

Drug: OxaliplatinDrug: CapecitabineRadiation: RadiotherapyProcedure: Surgery

Low instensity group

ACTIVE COMPARATOR

(RT 50Gy + CapOx) + Surgery

Drug: OxaliplatinDrug: CapecitabineRadiation: RadiotherapyProcedure: Surgery

Interventions

OxaliplatinDRUG

CRT:50mg/m2,IV,weekly\*5 cycle CT: 130mg/m2,IV,d1,q 21 day

High intensity groupLow instensity group
CapecitabineDRUG

CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks

High intensity groupLow instensity group
RadiotherapyRADIATION

High intensity group:55Gy Low intensity group:50Gy

High intensity groupLow instensity group
SurgeryPROCEDURE

Lower anterior resection or abdominoperineal resection

High intensity groupLow instensity group

Eligibility Criteria

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

You may qualify if:

  • Patients with rectal adenocarcinoma
  • Clinical staged T3/4 or any node-positive disease
  • Age: 18-75 years
  • Karnofsky Performance Status \> 80
  • Adequate bone marrow reserve, renal and hepatic functions
  • Without previous antitumoural chemotherapy
  • No evidence of metastatic disease
  • Written informed consent before randomization

You may not qualify if:

  • Previous pelvis radiotherapy.
  • Previous antitumoural chemotherapy
  • Clinically significant internal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • Wang J, Guan Y, Gu W, Yan S, Zhou J, Huang D, Tong T, Li C, Cai S, Zhang Z, Zhu J. Long-course neoadjuvant chemoradiotherapy with versus without a concomitant boost in locally advanced rectal cancer: a randomized, multicenter, phase II trial (FDRT-002). Radiat Oncol. 2019 Nov 29;14(1):215. doi: 10.1186/s13014-019-1420-z.

    PMID: 31783766DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

OxaliplatinCapecitabineRadiotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTherapeutics

Central Study Contacts

Ji Zhu, MD

CONTACT

leo.zhu@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Division of Radiation Oncology,Cancer Hospital

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 9, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

December 1, 2014

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

CN(1)