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

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ClinicalTrials.gov Identifier: NCT02964468
Recruitment Status : Unknown
Verified November 2016 by Asunción Hervas, Grupo de Investigación Clínica en Oncología Radioterapia.
Recruitment status was:  Recruiting
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Asunción Hervas, Grupo de Investigación Clínica en Oncología Radioterapia

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).

Condition or disease Intervention/treatment Phase
Locally Advanced Rectal Cancer Radiation: 3DCRT treatment (sequential boost) Radiation: Dose Escalation Intensity Modulated Radiotherapy treatment Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Dose-escalation Trial of Radiotherapy in Patients With Locally Advanced Rectal Cancer
Study Start Date : September 2016
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : November 2018

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.





Primary Outcome Measures :
  1. Pathologic complete response [ Time Frame: Through study completion, an average of 2 years ]
    Pathologic evaluation of the surgical specimen

  2. Gastrointestinal toxicity [ Time Frame: Two years ]
    Gastrointestinal adverse events as assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. Tumor regression grade [ Time Frame: Through study completion, an average of two years ]
    Pathologic evaluation of the surgical specimen

  2. Disease free survival [ Time Frame: Three years ]
  3. Overall survival [ Time Frame: Five years ]
  4. Toxicity [ Time Frame: Two years ]
    Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis, proctitis, urinary frequency/urgency as per common toxicity criteria V4.03

  5. Quality of Life [ Time Frame: Three years after the study completion ]
    Assessed by EORTC QLQC30 and the QLQ-CR29 questionnaries



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964468


Contacts
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Contact: Fernando López Campos, Investigator flcampos@salud.madrid.org

Locations
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Spain
Hospital General de Elche Active, not recruiting
Elche, Alicante, Spain
Hospital Universitario Santiago de Compostela Active, not recruiting
Santiago de Compostela, La Coruña, Spain
Hospital Universitario Rey Juan Carlos Active, not recruiting
Mostoles, Madrid, Spain
Hospital de la Esperanza Barcelona Active, not recruiting
Barcelona, Spain
Consorcio Hospitalario Provincial de Castellón Active, not recruiting
Castellon, Spain
Hospital General Universitario de Ciudad Real Active, not recruiting
Ciudad Real, Spain
Hospital Universitario de Fuenlabrada Active, not recruiting
Fuenlabrada, Spain
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Fernando López Campos       flcampos@salud.madrid.org   
Principal Investigator: Fernando López Campos         
Principal Investigator: Asunción Hervás Morón         
Sub-Investigator: Margarita Martín Martín         
Hospital Universitario La Paz Active, not recruiting
Madrid, Spain
Hospital Universitario La Princesa Active, not recruiting
Madrid, Spain
Hospital Clínico Universitario de Valencia Active, not recruiting
Valencia, Spain
Sponsors and Collaborators
Grupo de Investigación Clínica en Oncología Radioterapia
Investigators
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Principal Investigator: Fernando López Campos, Investigator Hospital Universitario Ramón y Cajal
Principal Investigator: Asunción Hervás Morón, Investigator Hospital Universitario Ramón y Cajal

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Responsible Party: Asunción Hervas, Doctor, Grupo de Investigación Clínica en Oncología Radioterapia
ClinicalTrials.gov Identifier: NCT02964468     History of Changes
Other Study ID Numbers: RTRC--001
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Asunción Hervas, Grupo de Investigación Clínica en Oncología Radioterapia:
Rectal Cancer
IMRT
Radiation Dose Escalation

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases