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

Grupo de Investigación Clínica en Oncología Radioterapia

Status: Unknown

Conditions: Locally Advanced Rectal Cancer

Treatments: Radiation: 3DCRT treatment (sequential boost); Radiation: Dose Escalation Intensity Modulated Radiotherapy treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02964468

RTRC--001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 525 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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525 participants in 2 patient groups

Treatment with IMRT Dose Escalation

Experimental group

Description:

Dose Escalation Intensity Modulated Radiotherapy treatment

Treatment:

Radiation: Dose Escalation Intensity Modulated Radiotherapy treatment

Treatment with 3DCRT

Active Comparator group

Description:

3DCRT treatment (sequential boost)

Treatment:

Radiation: 3DCRT treatment (sequential boost)