NCT03479814

Brief Summary

Aim of the study is to evaluate achievement of complete pathologic response (pCR) in high-risk rectal cancer treated with neoadjuvant concomitant chemotherapy plus adaptive-intensity modulated imaging-guided radiotherapy

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
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

August 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

March 14, 2018

Last Update Submit

March 26, 2018

Conditions

Rectal CancerRadiotherapyNeoadjuvant Treatment

Keywords

rectal cancerneoadjuvant chemoradiationIMRT-SIBadaptive radiotherapy

Outcome Measures

Primary Outcomes (1)

  • complete pathological response (pCR)

    pCR is defined as ypT0N0

    6 weeks

Secondary Outcomes (5)

  • Acute toxicity

    6 months

  • Quality of Life (QoL)

    1 year

  • Late toxicity

    1 year

  • Dosimetric advantage of GTV-boost reduction

    6 weeks

  • Evaluation of PET-response as predictive factor

    1 year

Study Arms (1)

IMRT-SIB plus sequential IG-RT boost

EXPERIMENTAL

45 Gy plus 5 Gy concomitant boost are delivered to rectum and locoregional lymphnodes (25 fractions); sequential IG-RT (imaging guided-radiotherapy) boost of 5 Gy in 2 fractions is planned with 18-FDG-PET

Radiation: IMRT-SIB plus sequential IG-RT boost

Interventions

IMRT-SIB plus sequential IG-RT boostRADIATION
IMRT-SIB plus sequential IG-RT boost

Eligibility Criteria

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

You may qualify if:

  • histologically confirmed diagnosis of locally advanced rectal cancer (cT3N+, cT4Nx, local relapse, cT3N0); cT2N+ is acceptable if low rectum is involved
  • ECOG 0-2

You may not qualify if:

  • familial adenomatous polyposis (FAP), non-polyposis hereditary colorectal cancer, inflammatory bowel disease
  • severe cardiopathy
  • previous pelvic RT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alessio G Morganti, MD

    Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessio G Morganti, MD

CONTACT

0512143564alessio.morganti2@unibo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 27, 2018

Study Start

August 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)