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

NCT02964468 | Unknown DMC

• 1 other identifier: RTRC--001
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 9

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).

Conditions

Locally Advanced Rectal Cancer

Keywords

Rectal Cancer; IMRT; Radiation Dose Escalation

Outcome Measures

Primary Outcomes (2)

• Pathologic complete response

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

  Through study completion, an average of 2 years

• Gastrointestinal toxicity

  Gastrointestinal adverse events as assessed by CTCAE v4.0

  Two years

Secondary Outcomes (5)

• Tumor regression grade

  Through study completion, an average of two years

• Disease free survival

  Three years

• Overall survival

  Five years

• Acute Toxicity

  Two years

• Quality of Life during the treatment

  Three years after the study completion

Study Arms (2)

Treatment with IMRT Dose Escalation

EXPERIMENTAL

Dose Escalation Intensity Modulated Radiotherapy treatment

Radiation: Dose Escalation Intensity Modulated Radiotherapy treatment

Treatment with 3DCRT

ACTIVE COMPARATOR

3DCRT treatment (sequential boost)

Radiation: 3DCRT treatment (sequential boost)

Interventions

3DCRT treatment (sequential boost) RADIATION

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.

Treatment with 3DCRT

Dose Escalation Intensity Modulated Radiotherapy treatment RADIATION

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.

Treatment with IMRT Dose Escalation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo de Investigación Clínica en Oncología Radioterapia: lead

Study Sites (9)

Hospital General de Elche

Elche, Alicante, Spain

RECRUITING

Consorcio Hospitalario Provincial de Castellón

Castellon, Castellón, Spain

RECRUITING

Hospital Universitario Santiago de Compostela

Santiago de Compostela, La Coruña, Spain

RECRUITING

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de Fuenlabrada

Fuenlabrada, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Fernando López Campos, Investigator

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando López Campos, Investigator

CONTACT

flcampos@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 16, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)