Online Adaptive Radiation Therapy for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Rectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05911789
• Other study ID #: ART-rectal cancer
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 5, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Online adaptive radiation therapy
A dose of 45Gy will be delivered to planning target volume (PTV)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicities(CTCA	evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0	3 months for the start of treatment
Primary	Response rate after surgery	Clinical and pathological complete response and partial response rate after chemoradiotherapy	3 monsh after treatment
Secondary	Chronic toxicity	evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme	2 years after treatment
Secondary	Dose coverage of target volume (assessed by planing target volume V100%)	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.	Through study completion, an average of five month
Secondary	Margins for clinical target volume(CTV) and gross tumor volume (GTV)	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	Through study completion, an average of five month