NCT07775209Enrolling by invitationPhase 2
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 · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 2 Aug 2026
- Start date
- 26 Aug 2026
- Primary completion date
- 31 May 2039
- Lead sponsor
- University of Vermont Medical Center
- NCT number
- NCT07775209
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From 26 Aug 2026 to the primary completion date, 31 May 2039
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiation therapy
- 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
Other illness
- Uncontrolled intercurrent illness that, in the opinion of the investigator, would prevent safe receipt of radiation therapy or capecitabine
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Vermont Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.