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

NCT06035133 | Not Yet Recruiting

• 1 other identifier: K202108-27
• Study Type: interventional
• Target: 213
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• tumor regression grading, TRG

  Reference resist 1.1 rating

  one month after surgery

Study Arms (1)

radiotherapy removal TNT plus group

EXPERIMENTAL

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.

Drug: CapeOX + cetuximab; Drug: CapeOX + bevacizumab; Radiation: radiotherapy

Interventions

CapeOX + cetuximab 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.

radiotherapy removal TNT plus group

CapeOX + bevacizumab 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 removal TNT plus group

radiotherapy RADIATION

radiotherapy

radiotherapy removal TNT plus group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tang-Du Hospital: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Cetuximab; Bevacizumab; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Central Study Contacts

Nan Wang, Dr

CONTACT

15719286297; wangnandoc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: September 13, 2023
• Study Start: November 10, 2023
• Primary Completion: November 10, 2024
• Study Completion (Estimated): November 10, 2027
• Last Updated: September 13, 2023

Record last verified: 2023-09