Online Adaptive Radiation Therapy for Rectal Cancer

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Rectal Cancer

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05911789

Enrollment

Registered

2023-06-22

Start date

2023-08-05

Completion date

2025-06-01

Last updated

2023-08-01

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

Conditions

Rectal Cancer

Keywords

rectal cancer, adaptive radiation therapy

Brief summary

In the present study, the investigators will evaluate the efficacy, toxicities, and of online adaptive radiation therapy (ART) for patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

Interventions

RADIATIONOnline adaptive radiation therapy

A dose of 45Gy will be delivered to planning target volume (PTV)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. ≥18 years old; 2. Diagnose with rectal cancer; 3. T3-T4 or N+, and no distant metastasis 4. Neoadjuvant chemoradiotherapy intended; 5. Surgery is expected after neoadjuvant therapy; 6. ECOG score 0-2, expected to lie in the treatment bed for at least half an hour;

Exclusion criteria

1. With contraindications to rectal MRI; 2. Received surgery, radiotherapy or chemotherapy for rectal cancer; 3. History of pelvic radiotherapy.

Design outcomes

Primary

Measure	Time frame	Description
Acute toxicities(CTCA	3 months for the start of treatment	evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0
Response rate after surgery	3 monsh after treatment	Clinical and pathological complete response and partial response rate after chemoradiotherapy

Secondary

Measure	Time frame	Description
Chronic toxicity	2 years after treatment	evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Dose coverage of target volume (assessed by planing target volume V100%)	Through study completion, an average of five month	Planing target volume V100%, defined as the planing target volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.
Margins for clinical target volume(CTV) and gross tumor volume (GTV)	Through study completion, an average of five month	Margins needed in online ART for CTV to planning clinical target volume (PCTV) and GTV to planning gross tumor volume (PGTV) to cover inter/intra-fraction motion

Outcome results

None listed

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