Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy

Rectal Cancer Clinical Trial

Official title:

One Arm Exploratory Trial of Efficacy and Safety of TNT Plus Mode With Neoadjuvant Radiotherapy in the Treatment of Locally Advanced Medium-low Rectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06035133
• Other study ID #: K202108-27
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: November 10, 2027

Study information

• Verified date: September 2023
• Source: Tang-Du Hospital
• Contact: Nan Wang, Dr
• Phone: 15719286297
• Email: wangnandoc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

(1) To evaluate the oncological effects of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode on TRG, Anal sphincter preservation surgery rate / rectal preservation surgery rate, cCR rate, pCR rate and other oncological effects in patients with middle and low LARC; (2) Evaluate the R0 resection rate, LARS score, urination function and sexual function score, local recurrence rate, and 3-year DFS and OS of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode, resolve the current dispute about the Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT treatment mode of LARC, provide a new mode for LARC treatment, and hopefully rewrite the diagnosis and treatment guidelines for rectal cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 213
• Est. completion date: November 10, 2027
• Est. primary completion date: November 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 70;

• Histologically confirmed adenocarcinoma of rectum;

• The distance from the lower edge of the tumor to the anus is = 10cm;

• ECOG score = 1;

• Have not received any anti-tumor treatment before;

• Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2; M0 chest and abdomen CT showed no obvious metastasis. (Note: PET-CT is recommended when small nodules can not be identified by liver or lung CT, and can still be included in the group when considering the possibility of metastasis)

• Hematological indicators and liver and kidney function within 7 days are within the normal range;

• Sign the informed consent form and be able to follow the research and /or follow-up procedures.

Exclusion Criteria:

• Have serious basic diseases, such as heart disease, renal failure, severe liver failure or liver failure, coagulation dysfunction, etc; Postoperative recurrence of colorectal cancer;

• The patient had a history of malignant tumor within 5 years;

• Pregnant or lactating women;

• The patient has a history of adjuvant radiotherapy for other system diseases, and surgical contraindications, so it is not suitable for surgery;

• The patient has had radiotherapy and chemotherapy records before this visit;

• Distant metastasis was found during operation;

• Patients with poor radiotherapy compliance and difficult cooperation;

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• CapeOX + cetuximab
CapeOX + cetuximab for RAS wild-type patients and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.
• CapeOX + bevacizumab
CapeOX + bevacizumab for RAS mutant patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.

Radiation:
• radiotherapy
radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor regression grading, TRG	Reference resist 1.1 rating	one month after surgery