Incidence of acute gastrointestinal toxicity in cervical cancer patients receiving daily online adaptive intensity modulated radiotherapy: A single-arm phase II trial

AI-Enhanced Adaptive Intensity-Modulated Radiotherapy for Cervical Cancer (AIM-C)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260216001

Enrollment

Registered

2026-02-16

Start date

2022-10-27

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Acute toxicities in cervical cancer patients receiving definitive concurrent chemoradiation with daily online adaptive radiotherapy Uterine Cervical Neoplasms Radiotherapy, Intensity-Modulated Adaptive Radiotherapy Image-Guided Radiotherapy Cone-Beam Computed Tomography Brachytherapy Chemoradiotherapy

Interventions

Daily online adaptive intensity-modulated radiation therapy (IMRT) 45 Gy in 25 daily fractions using the linear accelerator ETHOS to the PTV with a minimum of five cycles of concurrent weekly cisplati

Experimental Radiation

Daily online adaptive radiotherapy

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female 2. Age at least 18 years 3. Biopsy-proven squamous cell carcinoma or adenocarcinoma or adenosquamous carcinoma of the uterine cervix classified as FIGO 2018 stage IB3 to IIIC1

Exclusion criteria

Exclusion criteria: 1. More than three pelvic lymph nodes, paraaortic or inguinal lymph node involvement 2. Presence of distant metastasis 3. previous radiation therapy to the pelvis 4. post hysterectomy status 5. underlying inflammatory bowel disease 6. abnormal renal function (defined as creatinine clearance (CrCl) less than 60 mL/min based on Cockcroft-Gault equation) 7. patients with inadequate bone marrow function (White blood cells count <3,000 cells/cumm, absolute neutrophils count <1,500 cells/cumm, hemoglobin <9.0 g/dL, platelets <100,000/uL)

Design outcomes

Primary

Measure	Time frame
Acute gastrointestinal adverse events within 90 days after the end of radiotherapy Common Terminology Criteria for Adverse Events (CTCAE) grading	—

Secondary

Measure	Time frame
Acute genitourinary adverse events within 90 days after the end of radiotherapy Common Terminology Criteria for Adverse Events (CTCAE) grading,Acute hematologic adverse events within 90 days after the end of radiotherapy Common Terminology Criteria for Adverse Events (CTCAE) grading,Dosimetric parameters at the end of intervention Equivalent Dose in 2 Gy fractions formula,Local failure-free survival 2 year obtained from clinical follow-up records.,overall survival 2 year obtained from clinical follow-up records.	—

Measure

Time frame

Acute genitourinary adverse events within 90 days after the end of radiotherapy Common Terminology Criteria for Adverse Events (CTCAE) grading,Acute hematologic adverse events within 90 days after the end of radiotherapy Common Terminology Criteria for Adverse Events (CTCAE) grading,Dosimetric parameters at the end of intervention Equivalent Dose in 2 Gy fractions formula,Local failure-free survival 2 year obtained from clinical follow-up records.,overall survival 2 year obtained from clinical follow-up records.

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Countries

Thailand

Contacts

Public ContactAjcharee Nuengsigkapain

Faculty of Medicine, Chulalongkorn University

workpraew@gmail.com22564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026