Clinical trial · Observational
Predictive Value of 18F-FAZA in Rectum Cancer
The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer
NCT01257035CI-TRIAL-00010729FAZAterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The logistics of this trial (incl. supply of tracer) in connection with the patients' treatment course caused the inclusion rate to be very slow.
Summary
Brief summary (as posted)
The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectum Cancer | Rectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FAZA-PET/CT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 18F-FAZA-PET/CT
- interventionNames
- Other: 18F-FAZA-PET/CT
Primary outcomes (1)
- measure
- Response to chemoradiotherapy measured by TRG
- timeFrame
- 8 weeks after chemoradiation treatment
Secondary outcomes (2)
- measure
- Recurrence free survival
- timeFrame
- From date of inclusion till date of verified recurrence
- measure
- Survival
- timeFrame
- From date of inclusion till date of death by any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopatologically verified adenocarcinoma in the rectum * T4 tumor eller T3 tumor \< 10 cm from the anus and \< 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is \< 5 mm and therefore all T3 tumors are included in this area * Suitable for preoperative radiation and chemotherapy * No distant metastases * Age \>18 years * Hematology ANC ≥1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l. * Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL * Creatinine ≤ UNL * Contraception for fertile women * Written and orally informed consent Exclusion Criteria: * Other malignant disease within 5 years, excl. non-melanotic skin cancer * Previous radiation treatment of the pelvis * Pregnant or breastfeeding women * Surgery within 6 weeks prior to enrollment * Serious concurrent medical disease * Enrollment in study "A prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy", where the patients are potientially not operated.
References
Publications (0)
Data not yet available
No reference posted for this study.