Multicenter Dose-escalation Trial of Radiotherapy in Patients With Locally Advanced Rectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Locally Advanced Rectal Cancer
- Sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- Enrollment
- 525
- Locations
- 9
- Primary Endpoint
- Pathologic complete response
- Last Updated
- 6 years ago
Overview
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.
Investigators
Fernando Campos
Doctor
Grupo de Investigación Clínica en Oncología Radioterapia
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
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
Outcomes
Primary Outcomes
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
Gastrointestinal toxicity
Time Frame: Two years
Gastrointestinal adverse events as assessed by CTCAE v4.0
Secondary Outcomes
- Tumor regression grade(Through study completion, an average of two years)
- Disease free survival(Three years)
- Overall survival(Five years)
- Acute Toxicity(Two years)
- Quality of Life during the treatment(Three years after the study completion)