Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients
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ClinicalTrials.gov Identifier: NCT06043999 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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Condition or disease | Intervention/treatment | Phase |
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Chemotherapy Effect Rectal Cancer | Procedure: Radical total mesorectal excision Other: Salavge Adjuvant Chemoradiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 392 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multicenter, Randomized, Open, Parallel Controlled, Non-inferiority Clinical Trial of Salvage Chemoradiotherapy Versus Radical Total Mesorectal Excision in the Treatment of Intermediate-risk Early Middle-low Rectal Cancer After Local Resection |
Actual Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | December 31, 2028 |
Estimated Study Completion Date : | December 31, 2028 |
Arm | Intervention/treatment |
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Experimental: Salvage adjuvant chemoradiotherapy group
Patitents under local radical resection of rectal adenocarcinoma received:
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Other: Salavge Adjuvant Chemoradiotherapy
Concurrent adjuvant chemotherapy:5-Fu or 5-Fu analogues based chemotherapy regimens were selected. CapeOx or capecitabine monotherapy or FOLFOX is recommended, and no more than 3 months.Adjuvant radiotherapy protocol:long-course radiotherapy protocol.a. Target definition: areas at high risk for recurrence of the primary tumor and regional lymphatic drainage.b. Radiotherapy technology: conventional radiotherapy, three-dimensional conformal radiotherapy, intensity modulated radiotherapy, image guided radiotherapy, etc.c. Radiation dose:DT of 45Gy,1.8Gy per fraction in 25 fractions, was recommended for the high-risk recurrence area of the primary tumor and the regional lymphatic drainage area. |
Active Comparator: Radical TME group
Patitents under local radical resection of rectal adenocarcinoma received: Standard TME surgery was performed 3-4 weeks after local resection. |
Procedure: Radical total mesorectal excision
Standard TME surgery was performed 3-4 weeks after local resection. The operation is roughly divided into the following steps:After abdominal exploration, gradually ligation and from the inferior mesenteric vessels, pay attention to protect the left ureter, reproductive blood vessels and upper abdominal nerve; The descending colon was fully mobilized and the splenic flexure was mobilized if necessary. Follow the principle of TME, perform sharp resection of the total mesorectum, and pay attention to the protection of the prostate, vagina, pelvic nerve, etc.For can be removed through double stapling technique in low former (LAR) need not inline sphincter resection (excluding cases), to must be inline sphincter resection can be turned to the anus operation (ditto), consistent way can choose according to the intraoperative situation drag anastomosis or manual suture or stapling anastomosis. Prophylactic loop colostomy of transverse colon or ileostomy is recommended. |
- Three years disease-free survival rate [ Time Frame: 3 years after intervention ]Disease-free survival was defined as the absence of clinical, radiologic, or pathological (consistent with the pathological type of the primary tumor) evidence of recurrence on systemic examination, colonoscopy, CT/MRI, PET-CT, or needle biopsy (if necessary)
- Three years local recurrence rate [ Time Frame: 3 years after intervention ]Local tumor recurrence was defined as evidence of clinical, imaging, or pathological (consistent with the pathological type of the primary tumor) recurrence found in the pelvic region by digital rectal examination, colonoscopy, CT/MRI, PET-CT, or needle biopsy (if necessary)
- Three years overall survival rate [ Time Frame: 3 years after intervention ]OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
- Five years disease-free survival [ Time Frame: 5 years after intervention ]Defined as the proportion of patients who did not experience any of the following events from the beginning of the randomized subgroup to the end of the third year, which included disease progression, local recurrence, distant metastasis, or second primary colorectal cancer, or death from any cause.
- five years overall survival [ Time Frame: 5 years after intervention ]OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
- Anal function [ Time Frame: up to 24 weeks year after intervention ]wexner incontience score (0-20 0:poor 20:best)
- sexual function [ Time Frame: up to 24 weeks after intervention ]IIEF5 score evaluates erectile function in men {1-25noninterpretable score (score between 1 and 4), severe erectile dysfunction (score between 5 and 10), moderate erectile dysfunction (score between11 and 15), mild erectile dysfunction (score between 16 and 20), and normal erectile function (score between 21 and25)}
- EORTC QLQ-C30 [ Time Frame: up to 24 weeks after intervention ]evalution quality of life (0-100 0:poor 100:best)
- Urinary function [ Time Frame: up to 24 weeks after intervention ]IPSS score assesses the urinary functional results in men (0-35 0:best 35: poor)
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- aged 18-75 years;
- Local radical resection of rectal adenocarcinoma (TEM, TAMIS, TSPM, EMR, ESD or polypectomy)
- pT1 with a diameter of 3-5 cm, or a maximum diameter of 3 cm, and at least poor differentiation and/or lymphovascular invasion and/or perineural invasion and/or SM3;
- The distance from the lower edge of the tumor to the anal verge was within 10cm on MRI at initial diagnosis;
- clinical stage N0M0 at initial diagnosis;
- no multiple colorectal cancer;
- The heart, lung, liver and kidney function can tolerate surgery;
- Patients and their families were able to understand and willing to participate in this study, and provided written informed consent
Exclusion Criteria:
- complicated with other malignant tumors or a previous history of malignant tumors;
- not suitable for subsequent chemoradiotherapy or surgery;
- a history of inflammatory bowl disease (IBD) or familial adenomatous polyposis (FAP);
- recently diagnosed with other malignant tumors;
- ASA physical status ≥ IV and/or ECOG performance status > 2 points;
- patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases can not tolerate surgery;
- a history of severe mental illness;
- pregnant or lactating women;
- Patients with other clinical or laboratory conditions were not considered to be eligible for the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043999
Contact: Liang Huang, phD | 15989101216 | huangl75@mail.sysu.edu.cn |
China, Guangdong | |
Gastrointestinal Hospital, Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510655 | |
Contact: Yanghong Deng, PhD 008613925106525 dengyanh@mail.sysu.edu.cn | |
Principal Investigator: Yanhong Deng, PhD |
Responsible Party: | Yanhong Deng, Clinical Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT06043999 |
Other Study ID Numbers: |
GIH-SCTVTMEFLR |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |