Evidence map›Paper›PMID 21431408›Full record

Trial reportAnnals of surgical oncology2011

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of a phase III randomized clinical trial.

Xiao-Jun Yang, Chao-Qun Huang, Tao Suo, Lie-Jun Mei, Guo-Liang Yang, Fu-Lin Cheng, Yun-Feng Zhou, Bin Xiong, Yutaka Yonemura, Yan Li

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05648487 (A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy), which is not on this map. Cited by 335 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
335citing papers in PubMed, 19 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05648487 phase2not yet recruitingnot on this mapstarted 2023, after this paper: background citation

A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Sintilimab in Gastric Cancer With Peritoneal Metastasis

TypeinterventionalSponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical UniversityRan2023 to 2027Enrolled46ConditionsGastric CancerArmsHIPEC,anti-PD-1 antibody Sintilimab (Tyvyt®), Chemotherapy,Surgery
3 · Its place in the literature

Who cites it

335 citing papers in PubMed, 19 syntheses or guidelines pooled it.

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  2. Intraperitoneal chemotherapy for gastric cancer.The Cochrane database of systematic reviews · 2025
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275 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Xiao-Jun YangDepartment of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China.
Chao-Qun Huang
Tao Suo
Lie-Jun Mei
Guo-Liang Yang
Fu-Lin Cheng
Yun-Feng Zhou
Bin Xiong
Yutaka Yonemura
Yan Li

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis randomized phase III study was to evaluate the efficacy and safety of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) for the treatment of peritoneal carcinomatosis (PC) from gastric cancer.

methodsSixty-eight gastric PC patients were randomized into CRS alone (n = 34) or CRS + HIPEC (n = 34) receiving cisplatin 120 mg and mitomycin C 30 mg each in 6000 ml of normal saline at 43 ± 0.5°C for 60-90 min. The primary end point was overall survival, and the secondary end points were safety profiles.

resultsMajor clinicopathological characteristics were balanced between the 2 groups. The PC index was 2-36 (median 15) in the CRS + HIPEC and 3-23 (median 15) in the CRS groups (P = 0.489). The completeness of CRS score (CC 0-1) was 58.8% (20 of 34) in the CRS and 58.8% (20 of 34) in the CRS + HIPEC groups (P = 1.000). At a median follow-up of 32 months (7.5-83.5 months), death occurred in 33 of 34 (97.1%) cases in the CRS group and 29 of 34 (85.3%) cases of the CRS + HIPEC group. The median survival was 6.5 months (95% confidence interval 4.8-8.2 months) in CRS and 11.0 months (95% confidence interval 10.0-11.9 months) in the CRS + HIPEC groups (P = 0.046). Four patients (11.7%) in the CRS group and 5 (14.7%) patients in the CRS + HIPEC group developed serious adverse events (P = 0.839). Multivariate analysis found CRS + HIPEC, synchronous PC, CC 0-1, systemic chemotherapy ≥ 6 cycles, and no serious adverse events were independent predictors for better survival.

conclusionsFor synchronous gastric PC, CRS + HIPEC with mitomycin C 30 mg and cisplatin 120 mg may improve survival with acceptable morbidity.

Indexed as

Hyperthermia, InducedAdenocarcinomaAdenocarcinoma, MucinousAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Signet Ring CellCarcinoma, Squamous CellChemotherapy, AdjuvantChemotherapy, Cancer, Regional PerfusionCisplatinCombined Modality TherapyFemaleHumansInjections, IntraperitonealMaleCisplatinMitomycin

Identifiers

PMID21431408
PMCPMC3087875

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.