Locally Advanced Rectal Cancer
Conditions
Keywords
Rectal Cancer, IMRT, Radiation Dose Escalation
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.
Interventions
RADIATION3DCRT 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.
RADIATIONDose 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.
Sponsors
Grupo de Investigación Clínica en Oncología Radioterapia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response | Through study completion, an average of 2 years | Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring |
| Gastrointestinal toxicity | Two years | Gastrointestinal adverse events as assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Five years | — |
| Tumor regression grade | Through study completion, an average of two years | Pathologic evaluation of the surgical specimen |
| Quality of Life during the treatment | Three years after the study completion | Assessed by EORTC QLQC30-CR29 questionnaries |
| Acute Toxicity | Two years | Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03 |
| Disease free survival | Three years | — |
Countries
Spain
Contacts
Primary ContactFernando López Campos, Investigator
Outcome results
None listed