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

June 24, 2019 updated by: Fernando Campos, Grupo de Investigación Clínica en Oncología Radioterapia

Multicenter Dose-escalation Trial of Radiotherapy in Patients With Locally Advanced Rectal Cancer

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

525

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Ciudad Real, Spain
        • Active, not recruiting
        • Hospital General Universitario de Ciudad Real
      • Fuenlabrada, Spain
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
        • Principal Investigator:
          • Fernando López Campos
        • Principal Investigator:
          • Asunción Hervás Morón
        • Sub-Investigator:
          • Margarita Martín Martín
      • Madrid, Spain
      • Valencia, Spain
    • Alicante
      • Elche, Alicante, Spain
    • Castellón
      • Castellón De La Plana, Castellón, Spain
        • Recruiting
        • Consorcio Hospitalario Provincial de Castellón
        • Contact:
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain
    • Madrid
      • Mostoles, Madrid, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with IMRT Dose Escalation
Dose Escalation Intensity Modulated Radiotherapy treatment
Radiation: Dose Escalation Intensity Modulated Radiotherapy treatment

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.
Active Comparator: Treatment with 3DCRT
3DCRT treatment (sequential boost)
Radiation: 3DCRT treatment (sequential boost)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic complete response
Time Frame: Through study completion, an average of 2 years
Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring
Through study completion, an average of 2 years
Gastrointestinal toxicity
Time Frame: Two years
Gastrointestinal adverse events as assessed by CTCAE v4.0
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor regression grade
Time Frame: Through study completion, an average of two years
Pathologic evaluation of the surgical specimen
Through study completion, an average of two years
Disease free survival
Time Frame: Three years
Three years
Overall survival
Time Frame: Five years
Five years
Acute Toxicity
Time Frame: Two years
Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03
Two years
Quality of Life during the treatment
Time Frame: Three years after the study completion
Assessed by EORTC QLQC30-CR29 questionnaries
Three years after the study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

Investigators

  • Principal Investigator: Fernando López Campos, Investigator, Hospital Universitario Ramón y Cajal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 12, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTRC--001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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