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Clinical study of neoadjuvant synchronous radiotherapy combined with Bai Ku Dong Fang in the treatment of locally advanced rectal cancer

Clinical study of neoadjuvant synchronous radiotherapy combined with Bai Ku Dong Fang in the treatment of locally advanced rectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000427
Enrollment
Unknown
Registered
2024-09-12
Start date
2024-09-30
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

rectal cancer

Interventions

Baikudongfang Group:Baikudongfang

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1: Age = 18 years. 2: Pathology confirmed the diagnosis of adenocarcinoma of the rectum. 3: Locally advanced (T3-T4 or N+) diagnosed by CT MRI and/or ultrasound endoscopy. 4: Subjects must have adequate organ function as assessed by laboratory findings 5: Men of childbearing potential and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent until 180 days after the end of concurrent radiotherapy. Females of childbearing potential include premenopausal females and females within 2 years of menopause. Women of childbearing potential must exclude pregnancy prior to concurrent radiotherapy.

Exclusion criteria

Exclusion criteria: (1) Patients with severe bleeding tendency and severe infection. (2) Patients who cannot cooperate with continuous follow-up. (3) Other primary malignancies other than radically treated locally curable malignancies (e.g. basal or squamous cell skin cancer superficial bladder cancer or carcinoma in situ of the prostate cervix or breast) that have developed within 5 years prior to synchronous radiotherapy. (4) Have uncontrollable co-morbidities including but not limited to symptomatic congestive heart failure uncontrollable hypertension unstable angina pectoris cardiac arrhythmia active peptic ulcers or bleeding disorders. (5) Patients with a history of alcohol or drug abuse. Translated with DeepL.com (free version)

Design outcomes

Primary

MeasureTime frame
CR Rate;

Secondary

MeasureTime frame
anal retention rate;Tumor downstaging rate;overall survival;median overall survival;2-year localized regional control rate;disease free survival;

Countries

China

Contacts

Public ContactWang Hao

Peking University Third Hospital

hhbysy@126.com+86 18611207267

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026