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

NCT02964468 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2019-06-26

No results posted yet for this study

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).

Conditions

  • Locally Advanced Rectal Cancer

Interventions

RADIATION

3DCRT 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.

RADIATION

Dose 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 & Collaborators

  • Grupo de Investigación Clínica en Oncología Radioterapia

    lead OTHER

Principal Investigators

  • Fernando López Campos, Investigator · Hospital Universitario Ramón y Cajal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-05-31
Completion
2020-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964468 on ClinicalTrials.gov