Validation of a Predictive Model After Complete Response in Rectal Cancer

NCT00969657 | Completed DMC

• 2 other identifiers: 605009-03-023
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

rectal cancer stage I-III; concurrent chemoradiotherapie; response prediction

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (ypT0N0)

  8-12 weeks after long-series chemoradiotherapy

Secondary Outcomes (1)

• Several extra outcomes are registered for research: Local relapse at 2 years, metastases free survival, survival and relapse free survival

  five years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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
• years or older
• Have given written informed consent before patient registration
• No previous radiotherapy to the pelvis

You may not qualify if:

• No adenocarcinoma histology
• History of prior pelvis radiotherapy

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

MAASTRO clinic

Maastricht, Limburg, 6201BN, Netherlands

Location

Related Publications (1)

• Roelofs E, Dekker A, Meldolesi E, van Stiphout RGPM, Valentini V, Lambin P. International data-sharing for radiotherapy research: an open-source based infrastructure for multicentric clinical data mining. Radiother Oncol. 2014 Feb;110(2):370-374. doi: 10.1016/j.radonc.2013.11.001. Epub 2013 Dec 3.

  PMID: 24309199 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum,plasma

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

• Philippe Lambin, prof

  Maastricht Radiation Oncology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2014
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

NL (1)