Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer
NCT ID: NCT02964468
Last Updated: 2019-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
525 participants
INTERVENTIONAL
2016-09-30
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment with IMRT Dose Escalation
Dose Escalation Intensity Modulated Radiotherapy treatment
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.
Treatment with 3DCRT
3DCRT treatment (sequential boost)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
90 Years
ALL
No
Sponsors
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Grupo de Investigación Clínica en Oncología Radioterapia
OTHER
Responsible Party
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Fernando Campos
Doctor
Principal Investigators
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Fernando López Campos, Investigator
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramón y Cajal
Locations
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Hospital General de Elche
Elche, Alicante, Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, Castellón, Spain
Hospital Universitario Santiago de Compostela
Santiago de Compostela, La Coruña, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RTRC--001
Identifier Type: -
Identifier Source: org_study_id
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