Prospective validation of a predictive model for pathologic complete response after chemoradiotherapy in rectal cancer: A prognostic study

Prospective validation of a predictive model for pathologic complete response after chemoradiotherapy in rectal cancer: A prognostic study - validation of a predictive model after complete response in rectal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33076

Enrollment

Registered

2009-07-15

Start date

2009-09-02

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer of the rectum/rectumcancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: • Not adenocarcinoma histology • History of prior pelvis radiotherapy • No contra-indication for PET-CT ( claustrofobia/allergy)

Design outcomes

Primary

Measure	Time frame
Prediction of pathological complete response (ypT0N0) 8-12 weeks after long-series chemoradiotherapy.	—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results