Clinical trial · Observational
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer
Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer
NCT03731130CI-TRIAL-00035649NEOCARErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional Outcome, oncological outcome and toxicity in patients treated with neoadjuvant short term radiation or long-term chemoradiation followed by surgery
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiation | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Radiation Therapy | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EORTC QLQ C30 | Other | — | UNRESOLVED |
| EORTC QLQ CR29 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- neoadjuvant short term radiation
- description
- Treatment with neoadjuvant short term radiation therapy (5x5 Gy) followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire.
- interventionNames
- Other: EORTC QLQ C30
- Other: EORTC QLQ CR29
- label
- neoadjuvant long-term chemoradiation
- description
- Treatment with neoadjuvant Long-term chemoradiation followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire
- interventionNames
- Other: EORTC QLQ C30
- Other: EORTC QLQ CR29
Primary outcomes (2)
- measure
- QoL (EORTC QLQC30) absolute values and change over time
- timeFrame
- short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven rectal Cancer without distant metastases * indication for neoadjuvant Radiation or chemoradiation therapy according to multidiciplinary Evaluation * age \>=18 years * written informed consent * ability to answer the standardized questionaires according to the treating physician Exclusion Criteria: * age \< 18 years * prior systemic therapy with regard to rectal Cancer * distant metastasis * second malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.