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Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03381352
Enrollment
27
Registered
2017-12-22
Start date
2015-12-02
Completion date
2020-12-31
Last updated
2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer

Keywords

Radiotherapy, Anal cancer, IMRT

Brief summary

The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.

Interventions

RADIATIONChemo-radiotherapy with IMRT technique

IMRT radiation technique; 50.4-54Gy/25F

DRUGCapecitabine

Capecitabine 825mg/m2 PO BID

DRUGMitomycin C

Mitomycin C 10mg/m2 D1,29 iv

Sponsors

Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* CT/MRI diagnosed stage cT1-4N0-3; * Histologically confirmed anal squamous carcinoma; * KPS \>= 70 * Adequate organ function; * No previous radiotherapy or chemotherapy; * No surgery.

Exclusion criteria

* Previous malignant cancer history; * Allegic to 5-fu or MMC

Design outcomes

Primary

MeasureTime frameDescription
Response rate8 weeks after IMRTTo evaluate response rate of IMRT with chemotherapy

Secondary

MeasureTime frameDescription
Adverse eventsfrom start of IMRT to 8 weeks after IMRTTo assess the adverse events of IMRT with chemotherapy

Countries

China

Contacts

Primary ContactNing Li, MD
lee_ak@163.com0086-13810381399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026