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

NCT ID: NCT06035133

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2027-11-10

Brief 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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiotherapy removal TNT plus group

Six induction chemotherapy rounds of the CapeOX regimen were administered. RAS, BRAF, and MSI were found when the first patients were examined. Patients were given CapeOX + cetuximab for RAS wild-type patients, CapeOX + bevacizumab for RAS mutant 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. A surgical procedure was carried out two weeks after consolidation chemotherapy ended.

Group Type: EXPERIMENTAL

CapeOX + cetuximab

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

radiotherapy

Intervention Type: RADIATION

radiotherapy

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

radiotherapy

radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Nan Wang, Dr

Role: CONTACT

wangnandoc@163.com

15719286297

Other Identifiers

K202108-27

Identifier Type: -

Identifier Source: org_study_id