NCT06035133Not yet recruiting
Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy
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
Source: ClinicalTrials.gov · Last updated 13 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
(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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 213 (estimated)
- First submitted
- 22 Dec 2022
- Start date
- 10 Nov 2023
- Primary completion date
- 10 Nov 2024
- Lead sponsor
- Tang-Du Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06035133
What you commit to
- Study type: Interventional
- Planned participants: 213
- From 10 Nov 2023 to the primary completion date, 10 Nov 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient has had radiotherapy and chemotherapy records before this visit;
- Patients with poor radiotherapy compliance and difficult cooperation;
Other illness
- 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;
- The patient has a history of adjuvant radiotherapy for other system diseases, and surgical contraindications, so it is not suitable for surgery;
Other
- Pregnant or lactating women;
- Distant metastasis was found during operation;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.