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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with IMRT Dose Escalation | Experimental | Dose Escalation Intensity Modulated Radiotherapy treatment |
|
| Treatment with 3DCRT | Active Comparator | 3DCRT treatment (sequential boost) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3DCRT treatment (sequential boost) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response | Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring | Through study completion, an average of 2 years |
| Gastrointestinal toxicity | Gastrointestinal adverse events as assessed by CTCAE v4.0 | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor regression grade | Pathologic evaluation of the surgical specimen | Through study completion, an average of two years |
| Disease free survival | Three years |
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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:
Patient must sign study specific informed consent prior to study entry
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando López Campos, Investigator | Contact | flcampos@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Fernando López Campos, Investigator | Hospital Universitario Ramón y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Elche | Recruiting | Elche | Alicante | Spain |
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|
| Dose Escalation Intensity Modulated Radiotherapy treatment | Radiation | 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. |
|
| Overall survival | Five years |
| Acute Toxicity | Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03 | Two years |
| Quality of Life during the treatment | Assessed by EORTC QLQC30-CR29 questionnaries | Three years after the study completion |
| Consorcio Hospitalario Provincial de Castellón | Recruiting | Castellon | Castellón | Spain |
|
| Hospital Universitario Santiago de Compostela | Recruiting | Santiago de Compostela | La Coruña | Spain |
|
| Hospital Universitario Rey Juan Carlos | Recruiting | Móstoles | Madrid | Spain |
|
| Hospital General Universitario de Ciudad Real | Active, not recruiting | Ciudad Real | Spain |
| Hospital Universitario de Fuenlabrada | Recruiting | Fuenlabrada | Spain |
|
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
|
| Hospital Universitario La Paz | Recruiting | Madrid | Spain |
|
| Hospital Clínico Universitario de Valencia | Recruiting | Valencia | Spain |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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