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

NCT ID: NCT06194981

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2024-05-31

Brief 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.

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

3-4 months CapOx/SOX

Adjuvant CapOx/SOX 3-4 months after curative surgery:

CapOx: Oxaliplatin: 130 mg/m²/day (day 1) , Capecitabine: 1,000 mg/m², bid (day 1-14), q3W, total 3-4 months (4-6 cycles); SOX: Oxaliplatin: 130 mg/m2/day(day 1) , S-1: 40-60 mg, bid (day 1-14), q3W, total 3-4 months (4-6 cycles)

Oxaliplatin and capecitabine/ S-1 and capecitabine

Intervention Type: DRUG

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

5-6 months CapOx/SOX

Adjuvant CapOx/SOX 5-6 months after curative surgery:

CapOx: Oxaliplatin: 130 mg/m²/day (day 1) , Capecitabine: 1,000 mg/m², bid (day 1-14), q3W, total 5-6 months (7-8 cycles); SOX: Oxaliplatin: 130 mg/m2/day(day 1) , S-1: 40-60 mg, bid (day 1-14), q3W, total 5-6 months (7-8 cycles)

Oxaliplatin and capecitabine/ S-1 and capecitabine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Xeloda

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Hongyu Zhang

Attending doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongyu Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

Department of Gastrointestinal Surgery, the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongyu Zhang, M.D.

Role: CONTACT

hongyuzhang624@hotmail.com

+86 18339206109

Yang Fu, M.D.

Role: CONTACT

fuyang@zzu.edu.cn

+86 15516193215

Facility Contacts

Hongyu Zhang, MD

Role: primary

hongyuzhang624@hotmail.com

+8618339206109

Yang Fu, MD

Role: backup

fuyang@zzu.edu.cn

+8615516193215

References

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.

Reference Type: BACKGROUND

PMID: 25439693 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34252374 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29590544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33271092 (View on PubMed)

Other Identifiers

2023-KY-1488

Identifier Type: -

Identifier Source: org_study_id