Duration of Adjuvant Chemotherapy for Gastric Cancer Patients at Pathological N3 Stage

Gastric Cancer Clinical Trial

Official title:

Duration of Postoperative Adjuvant Chemotherapy (3-4 Months Versus 5-6 Months) for Gastric Cancer Patients at Pathological N3 Stage: a Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194981
• Other study ID #: 2023-KY-1488
• Status: Recruiting
• Start date: January 11, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Hongyu Zhang, M.D.
• Phone: +86 18339206109
• Email: hongyuzhang624[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this retrospective study is to compare the efficacy and safety of 3-4 months to 5-6 months of CapOx/SOX adjuvant chemotherapy in pathological N3 gastric cancer patients.

Description:

Due to a heavy metastatic node burden, pathological stage N3 (pN3) gastric cancer (GC) patients have extremely poor prognoses. Except for surgical resection, postoperative adjuvant chemotherapy is the major treatment strategy to improve survival for these patients. Capecitabine plus oxaliplatin (CapOx) and S-1 plus oxaliplatin (SOX) were considered the effective treatment for stage II and III GC after D2 gastrectomy in the CLASSIC and RESOLVE trials. But N3b (positive lymph nodes ≥16) and T1-3N3 patients were omitted in these two trials, respectively. Moreover, only 66.5% of patients finished 6 months of chemotherapy in the CLASSIC trial, and in the RESOLVE trial, 17-19% of patients required dose reductions and about 19% of patients discontinued chemotherapy due to drug-related toxicity for 6 months of chemotherapy. Particularly, cumulative administration of oxaliplatin led to peripheral sensory neurotoxicity, which caused poor quality of life and treatment compliance. Recently, a prospective analysis of six randomized, phase 3 trials with 12834 participants (IDEA trail) for stage III colon cancer, demonstrated that 3 months of CapOx was as effective as 6 months with relatively lower recurrence risk, no significantly different overall survival, and fewer adverse effects. However, there were no relevant studies to explore the optimal duration of chemotherapy for pN3 GC patients.

This study aims to compare the efficacy and safety of 3-4 months to 5-6 months of CapOx/SOX adjuvant chemotherapy in pathological N3 gastric cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: May 31, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18-80 years old

2. Pathological stage N3 GC (=7 positive lymph nodes) after curative surgery according to the AJCC TNM staging system, 8th edition

3. Histologically confirmed R0 resection, defined as no macroscopic or microscopic residual tumor

4. Postoperative chemotherapy with CapOX or SOX doublet regimen, initiating within 6 weeks after curative gastrectomy

5. No distant metastases or gastric stump cancer

6. No other malignant tumors

Exclusion Criteria:

1. Patients who had undergone neoadjuvant chemotherapy or radiotherapy

2. Patients who received capecitabine or S-1 alone or combined with biological therapy, radiation therapy, or Immunosuppressive therapy

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin and capecitabine/ S-1 and capecitabine
Drug: capecitabine: 1000 mg/m² bid, po, d1-14, oxaliplatin: 130mg/m², iv drip for 2h, d1; S-1: BSA<1.25m², 40mg bid, 1.25m²=BSA=1.5m², 50mg bid, BSA>1.5m², 60mg bid, po, d1-14, oxaliplatin: 130mg/m², iv drip for 2h, d1

Locations

Country	Name	City	State
China	Department of Gastrointestinal Surgery, the First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (4)

Andre T, Meyerhardt J, Iveson T, Sobrero A, Yoshino T, Souglakos I, Grothey A, Niedzwiecki D, Saunders M, Labianca R, Yamanaka T, Boukovinas I, Vernerey D, Meyers J, Harkin A, Torri V, Oki E, Georgoulias V, Taieb J, Shields A, Shi Q. Effect of duration of adjuvant chemotherapy for patients with stage III colon cancer (IDEA collaboration): final results from a prospective, pooled analysis of six randomised, phase 3 trials. Lancet Oncol. 2020 Dec;21(12):1620-1629. doi: 10.1016/S1470-2045(20)30527-1. — View Citation

Grothey A, Sobrero AF, Shields AF, Yoshino T, Paul J, Taieb J, Souglakos J, Shi Q, Kerr R, Labianca R, Meyerhardt JA, Vernerey D, Yamanaka T, Boukovinas I, Meyers JP, Renfro LA, Niedzwiecki D, Watanabe T, Torri V, Saunders M, Sargent DJ, Andre T, Iveson T. Duration of Adjuvant Chemotherapy for Stage III Colon Cancer. N Engl J Med. 2018 Mar 29;378(13):1177-1188. doi: 10.1056/NEJMoa1713709. — View Citation

Noh SH, Park SR, Yang HK, Chung HC, Chung IJ, Kim SW, Kim HH, Choi JH, Kim HK, Yu W, Lee JI, Shin DB, Ji J, Chen JS, Lim Y, Ha S, Bang YJ; CLASSIC trial investigators. Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1389-96. doi: 10.1016/S1470-2045(14)70473-5. Epub 2014 Oct 15. — View Citation

Zhang X, Liang H, Li Z, Xue Y, Wang Y, Zhou Z, Yu J, Bu Z, Chen L, Du Y, Wang X, Wu A, Li G, Su X, Xiao G, Cui M, Wu D, Chen L, Wu X, Zhou Y, Zhang L, Dang C, He Y, Zhang Z, Sun Y, Li Y, Chen H, Bai Y, Qi C, Yu P, Zhu G, Suo J, Jia B, Li L, Huang C, Li F, Ye Y, Xu H, Wang X, Yuan Y, E JY, Ying X, Yao C, Shen L, Ji J; RESOLVE study group. Perioperative or postoperative adjuvant oxaliplatin with S-1 versus adjuvant oxaliplatin with capecitabine in patients with locally advanced gastric or gastro-oesophageal junction adenocarcinoma undergoing D2 gastrectomy (RESOLVE): an open-label, superiority and non-inferiority, phase 3 randomised controlled trial. Lancet Oncol. 2021 Aug;22(8):1081-1092. doi: 10.1016/S1470-2045(21)00297-7. Epub 2021 Jul 9. Erratum In: Lancet Oncol. 2021 Aug;22(8):e347. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	The overall survival (OS) will be calculated from the day of surgery to participant's death with any cause	3 years
Secondary	Disease Free Survival	The Disease Free Survival (DFS) will be calculated from the day of surgery to participant's recurrence or death with any cause	3 years
Secondary	Adverse Events	Adverse Events of Chemotherapy	6 months