Online Adaptive Radiation Therapy for Rectal Cancer

Phase 1

Not yet recruiting

• Conditions: Rectal Cancer
• Interventions: Radiation: Online adaptive radiation therapy

• Registration Number: NCT05911789
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-22
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-01
• Study Start: 2023-08-05
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Online adaptive radiation therapy	Online adaptive radiation therapy	Patients receive adaptive radiotherapy therapy and concurrent chemotherapy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
Chronic toxicity	2 years after treatment	evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
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