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Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer

NCT ID: NCT01515748

Last Updated: 2023-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-30

Study Completion Date

2021-12-13

Brief Summary

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Primary Objective:

\- To compare the 3-year progression free survival (PFS) in the two treatment arms.

Secondary Objectives:

* Overall survival (OS).
* Postoperative pathological stage and R0 (complete) resection rate.
* Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy.

Detailed Description

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Participants in the neoadjuvant chemotherapy arm were treated for 3 cycles (1 cycle is 21 days) before surgery and treated for a year with S-1. Participants in the adjuvant chemotherapy arm underwent surgery and were treated for a year with S-1. All participants were followed during and after the study treatment until death or disease progression, whichever comes first.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery + Adjuvant Chemotherapy (SC)

Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 milligrams per square meter (mg/m\^2) administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after End-of-Treatment (EOT) until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years).

Group Type OTHER

S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Neoadjuvant Chemotherapy +Surgery +Adjuvant chemotherapy (CSC)

Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m\^2 intravenously (IV) for greater than or equal to (\>=)1 hour (hr) on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m\^2 IV for \>=2 hr on Day 1 of each treatment cycle plus S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years).

Group Type EXPERIMENTAL

Docetaxel (XRP6976)

Intervention Type DRUG

Pharmaceutical form:solution for infusion Route of administration: intravenous

Oxaliplatin (SR96669)

Intervention Type DRUG

Pharmaceutical form:solution for infusion Route of administration: intravenous

S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Interventions

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Docetaxel (XRP6976)

Pharmaceutical form:solution for infusion Route of administration: intravenous

Intervention Type DRUG

Oxaliplatin (SR96669)

Pharmaceutical form:solution for infusion Route of administration: intravenous

Intervention Type DRUG

S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants with new histologically confirmed, newly diagnosed, localized gastric or gastro-oesophageal adenocarcinoma, that is considered resectable.
* Participants with clinical stage (T2-3/N(+), T4/N(+/-):N positive means greater than or equal to \[\>=\] 8 in hour axis).
* Signed informed consent.

Exclusion Criteria

* Aged less than (\<) 20 years or \>= 76 years. Performance status \>=2 in Eastern Cooperative Oncology Group (ECOG) scale
* The participants who had the history of other malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix which had been already successfully treated.
* Previous surgery on neoplasm of stomach.
* Participants who did not completely recovered from surgery.
* Distant metastases (M1) to other organs including distant nodal groups (retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node). severe/unstable angina, coronary artery bypass graft, congestive heart failure, transient ischemic attack within 6 months prior to enrollment in the study.
* Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy, for the currently treated gastric cancer.
* Participants with active infection or sepsis.
* Intolerance of oral taking or malabsorption: lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of S-1. Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine and indications of resorption disorders after intestinal surgery.
* Greater than or equal to grade 2 severe tumour haemorrhage.
* Simultaneous participation in another study, or participation in another study within 4 weeks of commencement of this study.
* Pregnant or lactating participants.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoon-Koo KANG, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Administrative Office

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kang YK, Kim HD, Yook JH, Park YK, Lee JS, Kim YW, Kim JY, Ryu MH, Rha SY, Chung IJ, Kim IH, Oh SC, Park YS, Cheong JH, Jeong O, Heo MH, Kim HK, Park C, Yoo CH, Kang SY, Zang DY, Jang YJ, Sul JY, Kim JG, Kim BS, Beom SH, Hwang JE, Ryu SW, Kook MC, Ryoo BY, Kim H, Yoo MW, Lee NS, Lee SH, Noh SH. Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer: Updated Overall Survival Outcomes From Phase III PRODIGY. J Clin Oncol. 2024 Sep 1;42(25):2961-2965. doi: 10.1200/JCO.23.02167. Epub 2024 Jul 12.

Reference Type DERIVED
PMID: 38996201 (View on PubMed)

Kang YK, Yook JH, Park YK, Lee JS, Kim YW, Kim JY, Ryu MH, Rha SY, Chung IJ, Kim IH, Oh SC, Park YS, Son T, Jung MR, Heo MH, Kim HK, Park C, Yoo CH, Choi JH, Zang DY, Jang YJ, Sul JY, Kim JG, Kim BS, Beom SH, Cho SH, Ryu SW, Kook MC, Ryoo BY, Kim HK, Yoo MW, Lee NS, Lee SH, Kim G, Lee Y, Lee JH, Noh SH. PRODIGY: A Phase III Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer. J Clin Oncol. 2021 Sep 10;39(26):2903-2913. doi: 10.1200/JCO.20.02914. Epub 2021 Jun 16.

Reference Type DERIVED
PMID: 34133211 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1127-0246

Identifier Type: OTHER

Identifier Source: secondary_id

EFC13833

Identifier Type: OTHER

Identifier Source: secondary_id

DOCET_R_05153

Identifier Type: -

Identifier Source: org_study_id