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

Not Applicable

• Conditions: Locally Advanced Rectal Cancer
• Interventions: Radiation: Dose Escalation Intensity Modulated Radiotherapy treatment; Radiation: 3DCRT treatment (sequential boost)

• Registration Number: NCT02964468
• Lead Sponsor: Grupo de Investigación Clínica en Oncología Radioterapia

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-12
• Study First Posted: 2016-11-16
• Primary Completion: 2019-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-26
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 525

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with IMRT Dose Escalation	Dose Escalation Intensity Modulated Radiotherapy treatment	Dose Escalation Intensity Modulated Radiotherapy treatment
Treatment with 3DCRT	3DCRT treatment (sequential boost)	3DCRT treatment (sequential boost)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Tumor regression grade	Through study completion, an average of two years	Pathologic evaluation of the surgical specimen
Disease free survival	Three years
Overall survival	Five years
Acute Toxicity	Two years	Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03
Quality of Life during the treatment	Three years after the study completion	Assessed by EORTC QLQC30-CR29 questionnaries

Trial Locations

Locations (9)

Hospital General de Elche; 🇪🇸 Elche, Alicante, Spain

Consorcio Hospitalario Provincial de Castellón; 🇪🇸 Castellón De La Plana, Castellón, Spain

Hospital Universitario Santiago de Compostela; 🇪🇸 Santiago de Compostela, La Coruña, Spain

Hospital Universitario Rey Juan Carlos; 🇪🇸 Mostoles, Madrid, Spain

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Spain