An investigator-initiated trial to investigate the utility of LUNAR-1 in colorectal cancer patients with resectable distant metastases

JRCT ID: jRCT2072220055

Registered date:05/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: patients scheduled for curative resection for metastasis of colorectal cancer
• Date of first enrollment: 16/02/2023
• Target sample size: 160
• Study type: Interventional

Intervention(s)

ctDNA test using LUNAR-1
Blood samples will be taken before surgery (in the case of a two-step surgery, before surgery for metastatic lesions), 28 days after surgery, 12, 24, 36, 48, 60, 72, 84, 96 weeks after surgery. The amount of blood will be 10 mL per test tube, and 4 test tubes will be collected.

postoperative adjuvant therapy
If the ctDNA test result is negative at 28 days after surgery, postoperative adjuvant therapy will not be administered.

Outcome(s)

Primary Outcome

1) Negative predictive value in ctDNA-negative patients at 28 days postoperatively.
2) Positive predictive value of ctDNA for recurrence during the postoperative observation period

Secondary Outcome

1) Lead time from the ctDNA detection to radiographic recurrence during the postoperative observation period
2) Sensitivity of ctDNA for recurrence during the postoperative observation period
3) ctDNA positive rate at each ctDNA sampling timepoint
4) the 2-year recurrence-free survival rate in the ctDNA-positive patients at 28 days postoperatively
5) Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.The patient was diagnosed with colorectal cancer based on histological diagnosis of the primary lesion.
2.The following metastatic lesions have been clinically diagnosed from colorectal cancer (regardless of whether they are synchronous or metachronous). Metastases involving multiple organs are also eligible.
1)lung metastasis (Less than 5 in preoperative diagnosis)
2)liver metastasis (any number)
3)peritoneal metastasis (Less than 5 in preoperative diagnosis)
4)extra-regional lymph node metastasis (Less than 3 in preoperative diagnosis)
5)ovarian metastasis
6)other metastases, such as adrenal or splenic metastases (confirm with coordinating physician prior to enrollment)
3.The distant metastases are diagnosed by one of following tests.
1)Chest CT (5 mm slices) (both plain and contrast-enhanced CT are acceptable)
2)Upper abdominal contrast-enhanced CT (5 mm slices) * or upper abdominal MRI (5 mm slices)
3)Pelvic contrast-enhanced CT (5 mm slices) * or pelvic MRI (5 mm slices)
*If the patient is allergic to contrast agent, plain CT is acceptable.
4.Surgical resection is planned for the primary and metastatic lesions. Distant metastases should be perfomed by one-stage surgery. However, two-stage surgery within 28 days is acceptable in cases of metastasis in the right or left lung. Either of the following cases are eligible.
1)R0 resection is planned for the both primary lesion and distant metastases. (Resection of the primary and metastatic lesions as a two-step surgery within 28 days is permitted. Resection of the primary tumor is performed first in the cases.)
2)R0 resection has been performed for the primary lesion, and the first R0 resection for a distant lesion is scheduled.
3)R0 resection has been performed for the primary and metastatic lesion, and the R0 resection for a distant lesion is scheduled.
5. Patients will be eligible only if the history of chemotherapy or radiotherapy for the primary or distant metastases meets either of the conditions 1) or 2) below.
1) Prior chemotherapy for the primary or metastatic lesion was performed, and at least 28 days have passed since the final dose of chemotherapy at the time of enrollment.
2) Preoperative radiotherapy was administered for the primary or previous metastatic lesion.
6.If metastases to the liver or lungs are present, the patient has no history of cryotherapy or thermocoagulation therapy such as radiofrequency cauterization (including concomitant administration at the time of resection of metastases to the liver).
7.Being aged 18 years or above at the time of obtaining written consent.
8.ECOG Performance Status (PS) of 0 or 1. For patients aged 75 years or above, only a PS 0 is acceptable.
9.The patient is able to have blood collected according to the Protocol for this Study after enrollment.
10.The patient has fulfilled all of the following test findings. (The latest test results within the period of 14 days before enrollment should be used. The day 1 week before the enrollment is acceptable)
1)Neutrophil count >= 1,500 / mm3
2)Platelet count >= 10 x 10^4 / mm3
3)GOT =<100 IU/L (If liver metastases are present, GOT =<150 IU/L)
4)GPT =< 100 IU/L (If liver metastases are present, GOT =<150 IU/L)
5)T. Bil =< 1.5 mg/dL
6)Cr =< 1.4 mg/dL
11.Written consent to participate in the study has been provided by the patient himself/herself.

Exclude criteria

1.The patient has active multiple cancer (synchronus multiple cancers, and metachronus multiple cancers with a disease-free period of 5 years or less. However, patients with intraepithelial or intramucosal cancer in any organ that is determined to have been cured with localized therapy can be enrolled)
2.In the case of female patients, the patient is possibly pregnant or is breastfeeding.
3.The patient has concurrent interstitial pneumonia, pulmonary fibrosis or severe emphysema.
4.The patient has concurrent psychiatric disease or psychiatric symptoms determined to make it difficult for the patient to participate in the clinical trial.
5.The patient is receiving continuous systemic steroid therapy (oral or intravenous).
6.The patient has concurrent diabetes mellitus that is being treated with continuous insulin administration or is poorly controlled.
7.The patient has concurrent poorly controlled hypertension.
8.The patient has a history of one or more of the following: serious heart disease, cardiac failure, myocardial infarction within the past 6 months or angina attacks within the past 6 months.
9.Patients whom the PI or investigators decided as inappropriate for the clinical trial.

Related Information

• Primary Sponsor: Oki Eiji