NCT02745639

Brief Summary

This was a prospective phase II study on patients with locally advanced rectal cancer or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

3.8 years

First QC Date

April 17, 2016

Last Update Submit

April 17, 2016

Conditions

Rectal Neoplasms

Keywords

rectal cancerradiotherapychemotherapyVMATtoxicity

Outcome Measures

Primary Outcomes (1)

  • Pathological response rate

    Pathological response was determined according to the TNM classification system of the American Joint Committee on Cancer. The complete resection of the tumor (R) with no histological proven residual disease in the surgical specimen, was defined as pathological complete response (pCR =pT0). Near complete response (pTmic) was defined as the presence of a number of neoplastic cells inferior to 10%.

    6-8 weeks after chemoradiotherapy

Secondary Outcomes (1)

  • Acute Toxicity

    During radiation treatment and at the first follow-up visit (4 weeks after RT).

Study Arms (1)

VMAT-SIB + XELOX

EXPERIMENTAL

A VMAT-SIB technique was used. Radiation dose prescribed to PTV2 was 45 Gy (1.8 Gy/fraction), five sessions weekly in 25 daily fractions. A simultaneous boost was delivered on PTV1 with a total dose of 57.5 Gy (2.3 Gy/fraction). Dose-volume histograms (DVHs) were calculated for the PTV1, PTV2 and Organs at risks. The prescribed concurrent chemotherapy consisted of oxaliplatin infusion 130 mg/m2 on days 1, 17, 35 and capecitabine 1650 mg/m2 daily (825 mg/m² twice daily, 5 days/week) over all the treatment.

Radiation: VMAT-SIBDrug: XELOX

Interventions

VMAT-SIBRADIATION

Radiation dose prescribed to PTV2 was 45 Gy (1.8 Gy/fraction), five sessions weekly in 25 daily fractions. A simultaneous boost was delivered on PTV1 with a total dose of 57.5 Gy (2.3 Gy/fraction). Dose-volume histograms (DVHs) were calculated for the PTV1, PTV2 and OARs. Patients were treated only if the relative variations of the bone markers between the images were within 3 mm along the three spatial directions. Planning and delivery processes underwent to systematic independent-check procedures.

VMAT-SIB + XELOX
XELOXDRUG

The prescribed concurrent chemotherapy consisted of oxaliplatin infusion 130 mg/m2 on days 1, 17, 35 and capecitabine 1650 mg/m2 daily (825 mg/m² twice daily, 5 days/week) over all the treatment. An adequate blood count was necessary to start each chemotherapy infusion. Adjuvant chemotherapy was recommended on patients with high risk factors at pathological examination and decision was left to medical oncologists discretion.

Also known as: Oxaliplatin + Capecitabine
VMAT-SIB + XELOX

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

XELOXOxaliplatinCapecitabine

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 Nucleosides

Study Officials

  • Alessio G Morganti, Professor

    Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Gastroenterology

Study Record Dates

First Submitted

April 17, 2016

First Posted

April 20, 2016

Study Start

February 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2015

Last Updated

April 20, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

International Journals