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

Locally Advanced Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02964468
• Other study ID #: RTRC--001
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: May 2020

Study information

• Verified date: June 2019
• Source: Grupo de Investigación Clínica en Oncología Radioterapia
• Contact: Fernando López Campos, Investigator
• Email: flcampos[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. completion date: May 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Consorcio Hospitalario Provincial de Castellón	Castellón De La Plana	Castellón
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital General de Elche	Elche	Alicante
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Rey Juan Carlos	Mostoles	Madrid
Spain	Hospital Universitario Santiago de Compostela	Santiago de Compostela	La Coruña
Spain	Hospital Clínico Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Investigación Clínica en Oncología Radioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic complete response	Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring	Through study completion, an average of 2 years
Primary	Gastrointestinal toxicity	Gastrointestinal adverse events as assessed by CTCAE v4.0	Two years
Secondary	Tumor regression grade	Pathologic evaluation of the surgical specimen	Through study completion, an average of two years
Secondary	Disease free survival		Three years
Secondary	Overall survival		Five years
Secondary	Acute Toxicity	Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03	Two years
Secondary	Quality of Life during the treatment	Assessed by EORTC QLQC30-CR29 questionnaries	Three years after the study completion