Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Dose Escalation Intensity Modulated Radiotherapy treatment

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.

3DCRT treatment (sequential boost)

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.

Fernando López Campos, Investigator

Sandra Miranda

Virginia Morillo

Paula Peleteiro

María Dolores De Las Peñas Cabrera

MªVictoria De Torres Olambrada

Fernando López Campos

Asunción Hervás Morón

Margarita Martín Martín

Isabel Rodríguez

Ester Jordá Sorolla

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.

Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer

Multicenter Dose-escalation Trial of Radiotherapy in Patients With Locally Advanced Rectal Cancer

Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring

Gastrointestinal adverse events as assessed by CTCAE v4.0

Pathologic evaluation of the surgical specimen

Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03

Assessed by EORTC QLQC30-CR29 questionnaries

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer	NCT02964468	Locally Advance...	3DCRT treatment... Dose Escalation...	18 Years - 90 Years	Grupo de Investigación Clínica en Oncología Radioterapia
Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer	NCT02964468	Locally Advance...	3DCRT treatment... Dose Escalation...	18 Years - 90 Years	Grupo de Investigación Clínica en Oncología Radioterapia
Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer	NCT02964468	Locally Advance...	3DCRT treatment... Dose Escalation...	18 Years - 90 Years	Grupo de Investigación Clínica en Oncología Radioterapia

Spots Global Cancer Trial Database for radiation dose escalation