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Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer

Primary Purpose

Locally Advanced Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
3DCRT treatment (sequential boost)
Dose Escalation Intensity Modulated Radiotherapy treatment
Sponsored by
Grupo de Investigación Clínica en Oncología Radioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer focused on measuring Rectal Cancer, IMRT, Radiation Dose Escalation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically proven diagnosis of adenocarcinoma of the rectum
  • Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum
  • Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least <11cm from the anal verge
  • Adequate liver/renal and haematological function.
  • Eastern Cooperative Oncology Group (ECOG) performance 0-2
  • Age ≥ 18 years

  • Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:

    • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
    • Platelets ≥ 100,000 cells/mm3
    • Haemoglobin ≥ 8.0 g/dl
    • Serum creatinine within normal institutional limits
    • Bilirubin within normal institutional limits
    • AST and ALT < 2.5 x the IULN
  • Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

  • Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Any evidence of distant metastases (M1)
  • A synchronous primary colon carcinoma

Sites / Locations

  • Hospital General de ElcheRecruiting
  • Consorcio Hospitalario Provincial de CastellónRecruiting
  • Hospital Universitario Santiago de CompostelaRecruiting
  • Hospital Universitario Rey Juan CarlosRecruiting
  • Hospital General Universitario de Ciudad Real
  • Hospital Universitario de FuenlabradaRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Clínico Universitario de ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment with IMRT Dose Escalation

Treatment with 3DCRT

Arm Description

Dose Escalation Intensity Modulated Radiotherapy treatment

3DCRT treatment (sequential boost)

Outcomes

Primary Outcome Measures

Pathologic complete response
Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring
Gastrointestinal toxicity
Gastrointestinal adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Tumor regression grade
Pathologic evaluation of the surgical specimen
Disease free survival
Overall survival
Acute Toxicity
Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03
Quality of Life during the treatment
Assessed by EORTC QLQC30-CR29 questionnaries

Full Information

First Posted
November 9, 2016
Last Updated
June 24, 2019
Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia
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1. Study Identification

Unique Protocol Identification Number
NCT02964468
Brief Title
Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer
Official Title
Multicenter Dose-escalation Trial of Radiotherapy in Patients With Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the increase of radiation dose administered in patients diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using IMRT (concomitant boost technique).
Detailed Description
The hypothesis that arises is an improvement in the proportion of pathological complete responses, resulting therapeutic gain, as a result of a higher dose of radiation delivered to the tumor volume without incurring a higher gastrointestinal toxicity to the patient or surgical complications later, thanks to the use of intensity modulated radiotherapy (concomitant boost technique) that allows us to significantly reduce the administered dose organs at risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Cancer
Keywords
Rectal Cancer, IMRT, Radiation Dose Escalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
525 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with IMRT Dose Escalation
Arm Type
Experimental
Arm Description
Dose Escalation Intensity Modulated Radiotherapy treatment
Arm Title
Treatment with 3DCRT
Arm Type
Active Comparator
Arm Description
3DCRT treatment (sequential boost)
Intervention Type
Radiation
Intervention Name(s)
3DCRT treatment (sequential boost)
Intervention Description
Radiotherapy: 3DCRT treatment (sequential boost) 25 fractions fraction 1,8Gy by administering a total dose of 45 Gy on tumor and lymph nodes and lymph node chains more pelvic margin determined according to protocol. 3 fractions fraction 1,8Gy by sequentially administering an additional dose of tumor and lymph nodes 5,4Gy on more margin. Chemotherapy: According to routine clinical practice of the participating centers.
Intervention Type
Radiation
Intervention Name(s)
Dose Escalation Intensity Modulated Radiotherapy treatment
Intervention Description
Radiotherapy: IMRT treatment (concomitant boost technique) 25 fractions fraction 2,15Gy by administering a total dose of tumor and lymph nodes 53,75Gy on more margin. Simultaneously we will proceed to the irradiation of pelvic lymph node chains according to protocol, a division of 1,8Gy per session until a total dose of 45 Gy. Chemotherapy: According to routine clinical practice of the participating centers.
Primary Outcome Measure Information:
Title
Pathologic complete response
Description
Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring
Time Frame
Through study completion, an average of 2 years
Title
Gastrointestinal toxicity
Description
Gastrointestinal adverse events as assessed by CTCAE v4.0
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Tumor regression grade
Description
Pathologic evaluation of the surgical specimen
Time Frame
Through study completion, an average of two years
Title
Disease free survival
Time Frame
Three years
Title
Overall survival
Time Frame
Five years
Title
Acute Toxicity
Description
Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03
Time Frame
Two years
Title
Quality of Life during the treatment
Description
Assessed by EORTC QLQC30-CR29 questionnaries
Time Frame
Three years after the study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically proven diagnosis of adenocarcinoma of the rectum Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least <11cm from the anal verge Adequate liver/renal and haematological function. Eastern Cooperative Oncology Group (ECOG) performance 0-2 Age ≥ 18 years Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3 Platelets ≥ 100,000 cells/mm3 Haemoglobin ≥ 8.0 g/dl Serum creatinine within normal institutional limits Bilirubin within normal institutional limits AST and ALT < 2.5 x the IULN Patient must sign study specific informed consent prior to study entry Exclusion Criteria: Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields Any evidence of distant metastases (M1) A synchronous primary colon carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando López Campos, Investigator
Email
flcampos@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando López Campos, Investigator
Organizational Affiliation
Hospital Universitario Ramón y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Elche
City
Elche
State/Province
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Miranda
Email
mirandal81@hotmail.com
Facility Name
Consorcio Hospitalario Provincial de Castellón
City
Castellón De La Plana
State/Province
Castellón
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Morillo
Email
vmorill@gmail.com
Facility Name
Hospital Universitario Santiago de Compostela
City
Santiago de Compostela
State/Province
La Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Peleteiro
Email
paula.peleteiro.higuero@sergas.es
Facility Name
Hospital Universitario Rey Juan Carlos
City
Mostoles
State/Province
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Dolores De Las Peñas Cabrera
Email
dolorescabrera@telefonica.net
Facility Name
Hospital General Universitario de Ciudad Real
City
Ciudad Real
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MªVictoria De Torres Olambrada
Email
mariavictoria.detorres@salud.madrid.org
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando López Campos
Email
flcampos@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Fernando López Campos
First Name & Middle Initial & Last Name & Degree
Asunción Hervás Morón
First Name & Middle Initial & Last Name & Degree
Margarita Martín Martín
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Rodríguez
Email
isabel.rodriguezr@salud.madrid.org
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ester Jordá Sorolla
Email
estherjordasorolla@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer

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