Clinical trial · Interventional
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
NCT06050707CI-TRIAL-00114218MAESTROrecruitingPhase 2ClinicalTrials.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)
The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.
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 |
|---|---|---|---|
| Anal Squamous Cell Carcinoma | Anal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy - High risk group | Radiation | — | UNRESOLVED |
| Radiotherapy - Intermediate risk group | Radiation | — | UNRESOLVED |
| Radiotherapy - Low risk group | Radiation | — | UNRESOLVED |
| Radiotherapy - Standard risk group | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in locoregional failure (LRF) at Year 2
- timeFrame
- 2 years
- description
- Any local or regional failure from the date of registration to the date of any of the local or regional failure.
Secondary outcomes (8)
- measure
- Presence of distant metastasis (DM)
- timeFrame
- 5 years
- description
- Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.
- measure
- Colostomy rate
- timeFrame
- 5 years
- description
- The presence of a colostomy until colostomy removal.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pathologically proven diagnosis of anal SCC. This may include tumors of non-keratinizing histology such as basoloid or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible. * Clinical stage T1-4 N0-1 M0 (the Union for International Cancer Control (UICC) / the American Joint Committee on Cancer (AJCC) 8th Ed) * Patients must be eligible for definitive RT or CRT * Must be ≥ 18 years of age * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: * Previous chemotherapy, RT or curative-intent surgical treatment (i.e. APR) for anal cancer. * Any previous RT to the abdomino-pelvic region that would result in overlap of RT volume for the current study. * Individuals with a history of a different malignancy except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
References
Publications (0)
Data not yet available
No reference posted for this study.