Management of LLN Metastasis in Locally Advanced Rectal Cancer: A Prospective Radiation Dose Escalation Study

Rectal Cancer Clinical Trial

Official title:

Management of Clinically Involved Lateral Lymph Node Metastasis in Locally Advanced Rectal Cancer: A Prospective Radiation Dose Escalation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991090
• Other study ID #: Dose-esclation-LLN
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: August 28, 2024

Study information

• Verified date: November 2022
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiaolin Pang, MD
• Phone: +86 13928734386
• Email: pangxl5[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, locally advanced rectal cancer (LARC) patients with lateral lymph node (LLN) metastasis would be enrolled. The LLNs with short axis (SA) ≥ 5 mm are considered metastatic.The safety of neoadjuvant chemoradiotherapy(nCRT) with a booster dose to 58Gy had been initially demonstrated in our previous research. The effective and safety of dose escalation of LLN in LARC patients, will be further verified in this prospective, clinical study.

Description:

This is a prospective, observational clinical study for validation the efficiency and safety of the dose escalation of LLN. Patients who have been pathologically diagnosed as rectal adenocarcinoma and defined as clinical T1-4N1-2M0 without distant metastasis will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University. Patients should have at least one LLN metastasis defined on primary MRI, and the data of primary pelvic MRI will be performed within two weeks before the beginning of enrollment. All patients should follow a standard treatment protocol, including concurrent neoadjuvant chemoradiotherapy (nCRT) with a dose boost of LLNs to 58Gy, TME surgery with or without LLND ( lateral lymph node dissection) and adjuvant chemotherapy. The regimen of chemotherapy and the way of operation should be depended on the MDT(multiply discipline treatment) decision. The restaged MRI scan would be performed 6-12 weeks after the last fraction of radiotherapy. The LLN response rate ( short axis < 5mm ) would be evaluated. This study is aimed to apply a new way to control LLN metastasis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: August 28, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• informed consent was signed ;

• Age 18-75;

• Pathologically confirmed rectal adenocarcinoma, colonoscopy,MRI, CT and other examinations confirmed that the tumor was located under peritoneal reflexion,

• clinical staging was T1-4N1-2M0, pelvic MRI evaluation showed at least one lateral lymph node with short diameter =5 mm;

• Pelvic MRI was evaluated no more than 14 days before enrollment;

• ECOG 0-2 points;

• No prior history of other malignant tumors, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.

Exclusion Criteria:

• Previous radiotherapy or surgical treatment for colorectal cancer (except biopsy for pathology);

• Whole body CT, MR or PET-CT (including at least chest, whole abdomen, and pelvis) confirmed distant metastasis (M1);

• Previous or coexisting active malignancies (other than malignant neoplasms that have received curable treatment and have not been present for more than 3 years or carcinoma in situ that can be cured by adequate treatment);

• Receiving major operations such as laparotomy, thoracotomy, laparoscopic resection of organs or serious external injuries within the previous 4 weeks;

• Active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina or myocardial infarction within the 12 months prior to study participation;

• Patients who have experienced thrombosis or embolism within the past 6 months have received radiotherapy or surgical treatment for rectal cancer (except biopsy for pathology)

• New York Heart Society (NYHA) Grade II or higher congestive heart failure;

• The presence of CTCAE grade 2 or above toxicity (except anemia, alopecia, and skin pigmentation) due to any previous treatment that has not resolved;

• Pregnant or lactating women;

• Accompany with any medical condition that would affect patient safety and study compliance;

• Patients determined by the investigator to be unsuitable for participation in this clinical trial.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• escalation dose of LLNs
The lymph nodes (SA = 5 mm) existed at the internal iliac and obturator would be delineated, named as GTVnd, and received a radiation dose boost of 58Gy.

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the responsive rate of dose escalation of LLN	the LLN responsive rate (short diameter < 5mm) of neoadjuvant chemoradiotherapy combined with dose escalation of LLN in the treatment of middle and low locally advanced rectal cancer	3 years
Secondary	prognosis outcome-3-year Local Recurrence	The 3-year Local Recurrence of LARC patients underwent neoadjuvant chemoradiotherapy combined with dose escalation of LLN	3 years
Secondary	prognosis outcome-3-year Lateral Local Recurrence	The 3-year Lateral Local Recurrence of LARC patients underwent neoadjuvant chemoradiotherapy combined with dose escalation of LLN	3 years