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…
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prediction of pathological complete response (ypT0N0) 8-12 weeks after
long-series chemoradiotherapy.
Secondary outcome
Several binary outcomes (assessed from pathology 8-12 weeks after long-series
chemoradiotherapy) are predicted for treatment adaptation:
1. TRG12 versus TRG34 (TRG: tumor regression grade, see Appendix F)
2. TRG1 versus TRG234
3. Percentage of ypT1-T2, N0
Background summary
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 in stead 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 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.
Study 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.
Study design
28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1
PET-CT scan
Before radiotherapie, on day 15 and 8 weeks after radiotherapy: blood sample
taken.
Study burden and risks
Venapunction 2x ( PET-CT) and 3x a blood sample will be taken, in total 1.5
hours of extra time.
dr. Tanslaan 12
6229ET Maastricht
NL
dr. Tanslaan 12
6229ET Maastricht
NL
Listed location countries
Age
Inclusion criteria
• Histological proven rectal cancer
• UICC stage I-III
• Only primary tumors; no recurrences
• 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
• Only patients treated with concurrent chemoradiation
Exclusion criteria
• Not adenocarcinoma histology
• History of prior pelvis radiotherapy
• No contra-indication for PET-CT ( claustrofobia/allergy)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27852.068.09 |