Neoplasms

Digestive System Diseases

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles

Immunonutrition （Su yusu） 250ml oral twice a day d1-d21

Immunonutrition （Su yusu)

fluorouracil based chemotherapy regimens

Xiujuan Qu

Xiujuan Qu, Doctor

Evaluate the effects of Suyusu (immunonutrition) in postoperative adjuvant chemotherapy for gastrointestinal cancer patients. The main endpoint of the study was the incidence of chemotherapy related adverse reactions (including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis) in patients after two cycles of chemotherapy. The secondary endpoint indicators were: quality of life score (EORTC-QLQ-C30), nutritional risk score (PG-SGA, NRS2002), nutritional assessment indicators, changes in immune microenvironment, analysis of psychological status, survival time (1-year progression free survival rate), treatment tolerance (dose intensity, rate of treatment interruption, delay), etc.

Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors

A Multicenter, Open-label, Parallel Controlled, Prospective Cohort Study Evaluating Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors

including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on.

EORTC(The European Organization for Reasearch and Treatment of Cancer)-QOL-C30 (Quality of Life Questionnare-Core 30), patients need to answer all the questions by circling the number (1,2,3,4), big number means the worse quality of life score

(PG-SGA) the patient-generated subjective global assessment. The result (A means well-nourished, B means middling-cacotrophia, C means severe malnutrition). Nutritional risk Screening Form 2002 (NRS2002), score ≥3 means patients with nutritional risk, score \<3 patients with no nutritional risk. We use the two methods to evaluate the nutritional risk score.

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

China Medical University, China

Clinical Professor

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Carboplatin

Etoposide

Cisplatin

Etoposide phosphate

Patients in the control group are enrolled in the follow-up, and the patients in research group will receive prophylactic cranial irradiation （PCI） by 25 gy/10 fx.

prophylactic cranial irradiation (PCI)

lobectomy + mediastinal lymph node dissection or systematic lymph node sampling

If the postoperatively pathological examination of the patient is confirmed to be in pT1-2N0 stage, a single postoperative adjuvant chemotherapy (combining etoposide with cisplatin) is recommended. If patients are difficult to tolerate the side effects of cisplatin, we can replace cisplatin by carboplatin in the adjuvant chemotherapy scheme.

postoperative adjuvant chemotherapy

Peng Zhang, Doctor

Peng Zhang, doctor

At present, for participants with cT1-2N0 small cell lung cancer (SCLC), the International guidelines recommend surgical radical resection (lobectomy + systematic lymph node sampling or cleaning); If the postoperatively pathological examination is confirmed to be in pT1-2N0 stage, a single postoperative adjuvant chemotherapy (combining etoposide with cisplatin) is recommended. If participants are difficult to tolerate the side effects of cisplatin, the investigators can replace cisplatin by carboplatin in the adjuvant chemotherapy scheme. Participants with pT1-2N0 SCLC are not recommended to receive postoperative chest-assisted radiotherapy. For participants with pT1-N0 SCLC after specific surgical resection, prophylactic cranial irradiation (PCI) is currently recommended. But this recommendation is currently lacking the support of research evidence.

The main purpose of this study is to study the prognostic effects of PCI on participants with pT1-2N0 stage small cell lung cancer (SCLC) who have received radical surgery and postoperative adjuvant chemotherapy.

The main endpoint of this study is to observe the total survival rate (5-year OS%) in 5 years.

The secondary outcome measures include 5 years of disease-free survival (5-year DFS%), disease-free survival (DFS), overall survival (OS), surgical complications, resection rates, quality of life (QoL), and exploration of biomarkers (tumor tissue).

This is a two-arm, open, multicentral clinical study designed to compare the 5-year OS% of participants receiving or not receiving PCI for pT1-2N0 stage small cell lung cancer (SCLC) with radical surgery plus postoperative adjuvant chemotherapy. Previous literature reports that the 5-year OS% of participants with pT1-2N0 period SCLC who have received surgical resection is about 50%. Assuming that PCI can increase 5 years OS% by 10%, then enrolling 320 participants in the group can guarantee 70% degree of certainty with observing a unilateral significant difference α\< 0.1. Taking about 10% of the follow-up loss rate into account, the investigators expect to enroll 360 participants.

Dividing the 360 participants divided into two groups randomly, each group is composed of 180 people. All participants received lobectomy plus mediastinal lymph node dissection or systematic lymph node sampling. Participants in the control group are enrolled in the follow-up, and the participants in research group will receive PCI by 25gy/10fx.

Clinical Study of Combined Radical Operation With Postoperative Adjuvant Chemotherapy and Prophylactic Cranial Irradiation in pT1-2N0M0 Stage of Small Cell Lung Cancer

Five-year survival rate measures survival at 5 years after surgery.

The rate that the patients whose disease doesn't recur take up in the total patients from the start of randomization to 5 years.

From the beginning of randomization to the time-point when the disease recurs or the patient dies due to disease progression.

Patients die directly from the progression of SCLC or from an unrelated cause (for example, a car accident). When the precise cause of death is not specified, this is called the overall survival rate.

The complications related to the operations that happen in the perioperative period.

The patients who are able to receive the radical resection.

To search the possible bio-makers for SCLC.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors	NCT06085365	Gastrointestina... Immunonutrition Postoperative A...	Immunonutrition... fluorouracil ba...	18 Years - 75 Years	China Medical University, China
Clinical Study of Combined Radical Operation With Postoperative Adjuvant Chemotherapy and Prophylactic Cranial Irradiation in pT1-2N0M0 Stage of Small Cell Lung Cancer	NCT03514849	Small-cell Lung...	prophylactic cr... lobectomy + med... postoperative a...	18 Years -	Shanghai Pulmonary Hospital, Shanghai, China
Clinical Study of Combined Radical Operation With Postoperative Adjuvant Chemotherapy and Prophylactic Cranial Irradiation in pT1-2N0M0 Stage of Small Cell Lung Cancer	NCT03514849	Small-cell Lung...	prophylactic cr... lobectomy + med... postoperative a...	18 Years -	Shanghai Pulmonary Hospital, Shanghai, China

Spots Global Cancer Trial Database for postoperative adjuvant chemotherapy