Clinical trial · Interventional
Shortening Radiation Course Duration Using Simultaneous Integrated Boost With Lower Intensity Elective Nodal Dosing and Concurrent Chemotherapy for High-Risk Anal Squamous Cell Carcinoma
Shortening Radiation Course Duration Via Simultaneous Integrated Boost With Lower Intensity Elective Nodal Dosing While Giving Concurrent Chemotherapy for High-risk Anal Squamous Cell Carcinoma - a Phase 2 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
This phase 2 single-arm study will evaluate whether a shortened course of mildly hypofractionated radiation therapy given with standard concurrent chemotherapy (mitomycin C and capecitabine) can provide acceptable tumor control in patients with high-risk non-metastatic anal squamous cell carcinoma. Standard chemoradiation for anal cancer typically requires approximately 5.5 to 6 weeks of daily radiation, which can create substantial logistical burden for patients and caregivers, particularly those in rural settings. The investigational approach uses a 23-fraction radiation regimen designed to shorten treatment duration while maintaining biologically equivalent tumor-directed dosing compared with standard treatment. The primary question is whether this shorter chemoradiation regimen can achieve an acceptable 6-month complete clinical response rate while maintaining manageable 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 Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Hypofractionated Chemoradiation
- description
- Participants receive mildly hypofractionated radiation therapy delivered in 23 fractions using a simultaneous integrated boost approach with concurrent standard-of-care mitomycin C and capecitabine chemotherapy.
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
Primary outcomes (1)
- measure
- Complete Clinical Response Rate at 6 Months
- timeFrame
- 6 months after start of radiation therapy
- description
- Proportion of participants achieving complete clinical response, defined as absence of tumor and malignant ulceration in the anal canal and perianal skin on digital rectal examination and/or anoscopy, with resolution of palpable inguinal lymphadenopathy if present at baseline. Biopsy may be used when clinically indicated to confirm persistent disease.
Secondary outcomes (16)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Histologically or cytologically confirmed non-metastatic anal squamous cell carcinoma meeting one of the following criteria: T2 tumor measuring ≥4 cm T3 or T4 disease Any node-positive disease * Patients with HPV-associated (p16-positive) perianal cancer are eligible if the tumor extends to the anal verge * Karnofsky Performance Status \>60 * Creatinine clearance \>30 mL/min * Considered by the investigator to be appropriate candidates for concurrent capecitabine and mitomycin C chemotherapy * Ability to understand and willingness to provide informed consent * For participants of childbearing potential: negative pregnancy test or documented absence of pregnancy per institutional standard within 14 days prior to registration * Participants of reproductive potential must agree to use adequate contraception during study treatment and for 90 days after completion of therapy Exclusion Criteria: * Prior pelvic radiation therapy * Uncontrolled intercurrent illness that, in the opinion of the investigator, would prevent safe receipt of radiation therapy or capecitabine * Prior or concurrent malignancy that, in the opinion of the investigator, could interfere with assessment of safety or efficacy * Current receipt of another investigational agent for treatment of anal squamous cell carcinoma
References
Publications (0)
Data not yet available