Clinical trial NCT02964468: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Locally Advanced Rectal Cancer
Keywords: Rectal Cancer
IMRT
Radiation Dose Escalation
Lead sponsor: Grupo de Investigación Clínica en Oncología Radioterapia
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pathologic complete response
timeFrame: Through study completion, an average of 2 years
measure: Gastrointestinal toxicity
timeFrame: Two years
Secondary outcomes:
measure: Tumor regression grade
timeFrame: Through study completion, an average of two years
measure: Disease free survival
timeFrame: Three years
measure: Overall survival
timeFrame: Five years
measure: Acute Toxicity
timeFrame: Two years
measure: Quality of Life during the treatment
timeFrame: Three years after the study completion
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General de Elche
state: Alicante
city: Castellón De La Plana
country: Spain
facility: Consorcio Hospitalario Provincial de Castellón
state: Castellón
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario Santiago de Compostela
state: La Coruña
city: Mostoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Hospital Universitario Ramón y Cajal
name: Fernando López Campos, Investigator
role: PRINCIPAL_INVESTIGATOR
References: