Validation of a Predictive Model After Complete Response in Rectal Cancer (Thunder)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00969657
First received: August 31, 2009
Last updated: April 19, 2012
Last verified: July 2011
  Purpose

Background of the study:

Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in individualizing treatment strategies, i.e., selecting patients who need less invasive surgery or another radiotherapy strategy instead of resection. For rectal cancer it is known that 10-30% of the patients will respond with a pathologic complete response (pCR) after CRT. From a retrospective study with multivariate analysis of both clinical and 2-[18F] fluoro-2-deoxy-D-glucose and positron emission tomography (FDG-PET) data, it was found that adding FDG-PET data collected before and after CRT leads to a more predictive model compared to evaluating only pretreatment clinical data. To validate this model, this registration study is proposed. Furthermore, it has been found that FDG-PET during treatment is very predictive for response and a more favorable time point to adapt treatment. Also, there are indications that adding blood biomarkers to the data, results in higher accuracy for response prediction compared to clinical and imaging data alone. Therefore, FDG-PET during treatment and blood sampling are included in the protocol to improve the accuracy of the prediction models.

Objective of the study:

The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient.

Study design:

28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1 PET-CT scan Before radiotherapy, on day 15 and 8 weeks after radiotherapy: blood sample taken.


Condition
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Validation of a Predictive Model for Pathologic Complete Response After Chemoradiotherapy in Rectal Cancer: A Prognostic Study

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Pathological complete response (ypT0N0) [ Time Frame: 8-12 weeks after long-series chemoradiotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Several extra outcomes are registered for research: Local relapse at 2 years, metastases free survival, survival and relapse free survival [ Time Frame: five years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum,plasma


Estimated Enrollment: 80
Study Start Date: August 2009
Estimated Study Completion Date: January 2017
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Detailed Description:

General objective

The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient.

Aim of the study

The main aim is to validate a predictive model for pathologic complete response (ypT0N0) in rectal cancer patients treated with chemoradiotherapy by multi-centric prospective data collection. The second aim is to collect extra data for improvement of the accuracy of the prediction models with new variables. This new model will be validated later in the model development process.

Hypothesis

General hypothesis:

The validated accuracy of predictive models for pathologic complete response after chemoradiotherapy in rectal cancer patients is high enough to tailor treatment (surgery/non-surgery and/or administer extra radiation boosts) in clinical practice.

Specific hypotheses:

  1. The performance of the developed models on the validation data is at least equal to the performance achieved during the model development process.
  2. The performance of a new model based on the addition of variables performs better than the previous model
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • Histological proven rectal cancer
  • UICC stage I-III
  • Only primary tumors; no recurrences
  • Only concurrent chemoradiotherapy treatment
  • Willing and able to comply with the study prescriptions
  • 18 years or older
  • Have given written informed consent before patient registration
  • No previous radiotherapy to the pelvis

Exclusion Criteria:

  • No adenocarcinoma histology
  • History of prior pelvis radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969657

Locations
Netherlands
MAASTRO clinic
Maastricht, Limburg, Netherlands, 6201BN
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Study Director: Philippe Lambin, prof Maastricht Radiation Oncology
  More Information

No publications provided

Responsible Party: MAASTRO clinic, prof. dr. PH Lambin, MAASTRO clinic
ClinicalTrials.gov Identifier: NCT00969657     History of Changes
Other Study ID Numbers: 6050, 09-03-023
Study First Received: August 31, 2009
Last Updated: April 19, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
rectal cancer stage I-III
concurrent chemoradiotherapie
response prediction

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014