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

• ClinicalTrials.gov Identifier: NCT06035133
• Recruitment Status: Not yet recruiting
• First Posted: September 13, 2023
• Last Update Posted: September 13, 2023
• Sponsor: Tang-Du Hospital
• Information provided by (Responsible Party): Tang-Du Hospital

Tracking Information

• First Submitted Date: December 22, 2022
• First Posted Date: September 13, 2023
• Last Update Posted Date: September 13, 2023
• Estimated Study Start Date: November 10, 2023
• Estimated Primary Completion Date: November 10, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2023)

tumor regression grading, TRG [ Time Frame: one month after surgery ]

Reference resist 1.1 rating

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rectal Cancer

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.
• 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.
• Radiation: radiotherapy
  radiotherapy

Study Arms

Experimental: 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.

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 12, 2023): 213
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 10, 2027
• Estimated Primary Completion Date: November 10, 2024 (Final data collection date for primary outcome measure)

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;

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Nan Wang, Dr; 15719286297; wangnandoc@163.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06035133
• Other Study ID Numbers: K202108-27
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Tang-Du Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Tang-Du Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Tang-Du Hospital
• Verification Date: September 2023