Clinical Trial Designs in Oncology

Korn, Edward L.; Freidlin, Boris

doi:10.1016/b978-0-323-47674-4.00018-9

Cited by 6 publications

(4 citation statements)

References 119 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The DFS was defined as the interval from the date of the operation to the recurrence of gastric cancer or death. 19 Recurrence was identified by medical history and physical examination in combination with imaging evaluation, cytologic analysis, or tissue biopsy (preferred when feasible). 11 To evaluate the therapeutic value of dissection at each LN station, we used the therapeutic value index proposed by Sasako et al 20 The frequency of metastasis to each station was then calculated by dividing the number of patients with metastasis at that station by the number in whom the station was dissected.…”

Section: Methodsmentioning

confidence: 99%

“…The OS was calculated from the date of surgery to the date of last contact or death. The DFS was defined as the interval from the date of the operation to the recurrence of gastric cancer or death . Recurrence was identified by medical history and physical examination in combination with imaging evaluation, cytologic analysis, or tissue biopsy (preferred when feasible) .…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Outcomes of Laparoscopic Total Gastrectomy Combined With Spleen-Preserving Hilar Lymphadenectomy for Locally Advanced Proximal Gastric Cancer

Zheng

Zhao

et al. 2021

JAMA Netw Open

View full text Add to dashboard Cite

IMPORTANCEThe long-term survival of patients with laparoscopic total gastrectomy combined with spleen-preserving splenic hilar lymphadenectomy (LSTG) for advanced upper-third gastric cancer (AUTGC) and the association of splenic hilar lymph node (LN-10) metastasis with survival remain controversial. OBJECTIVETo evaluate the long-term outcomes of LSTG and the value index of LN-10 metastasis for patients with AUTGC. DESIGN, SETTING, AND PARTICIPANTS The Chinese Laparoscopic Gastrointestinal Surgery Study 4 (CLASS-04) was a prospective, multicenter, single-arm trial that involved 19 centers in China. A total of 251 eligible patients with clinical stage T2, T3, or T4a upper-third gastric cancer without distant metastases were enrolled from September 1, 2016, to October 31, 2017. The final follow-up was on December 31, 2020. INTERVENTIONS All patients were enrolled to undergo LSTG. MAIN OUTCOMES AND MEASURESThe main outcomes were the 3-year overall survival (OS) and disease-free survival (DFS). Multivariate analyses were used to explore the association of LN-10 metastasis with survival. RESULTSAmong the 251 patients, 246 (98.0%; mean [SD] age, 60.1 [9.4] years; 197 [80.1%] male)underwent LSTG and completed the study. The 3-year OS was 79.1% (95% CI, 74.0%-84.2%), and the 3-year DFS was 73.1% (95% CI, 67.4%-78.8%). In addition, the 3-year therapeutic value index of LN-10 dissection was 4.5, exceeding the indexes for the partial D2 LN group (including LNs 5, 6, 11d, and 12a). Nineteen patients (7.7%) with LN-10 metastasis had significantly worse survival than the nonmetastasis group, and multivariate analysis revealed that splenic LN-10 metastasis was an independent risk factor (OS: hazard ratio [HR], 2.38; 95% CI, 1.08-5.26; P = .03; DFS: HR, 2.28; 95% CI, 1.12-4.63; P = .02). Moreover, patients with LN-10 metastasis were more likely to have recurrence (42.1% vs 20.7%, P = .03), especially when multiple site metastasis was present (21.1% vs 4.4%, P = .01). However, patients with LN-10 metastasis who received adjuvant chemotherapy had significantly better OS and DFS than those without adjuvant chemotherapy and achieved the same oncologic effect as those without LN-10 metastasis. (continued) Key Points Question What are the 3-year outcomes after laparoscopic total gastrectomy combined with spleenpreserving splenic hilar lymphadenectomy for patients with locally advanced proximal gastric cancer? Findings In this nonrandomized clinical trial of 251 patients with clinically staged, locally advanced upper-third gastric cancer, the 3-year overall survival was 79.1%. The 3-year therapeutic value index of lymph node 10 dissection was 4.5, exceeding the index for the partial D2 lymph node group. Meaning The findings of this study suggest the utility of laparoscopic total gastrectomy combined with spleenpreserving splenic hilar lymphadenectomy for clinically staged, locally advanced upper-third gastric cancer.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Outcomes of Laparoscopic Total Gastrectomy Combined With Spleen-Preserving Hilar Lymphadenectomy for Locally Advanced Proximal Gastric Cancer

Zheng

Zhao

et al. 2021

JAMA Netw Open

View full text Add to dashboard Cite

show abstract

“…It is worth exploring the seamless clinical trials with urn models. Second, research on adaptive randomization design and ASD under the Bayesian framework includes but is not limited to [3,6,7,12,28,29,54,66,67]. We can comprehensively compare our methods with the bayesian approaches.…”

Section: Discussionmentioning

confidence: 99%

Seamless Clinical Trials with Doubly Adaptive Biased Coin Designs

Zhu¹,

Yu²,

Lai³

et al. 2023

The New England Journal of Statistics in Data Science

View full text Add to dashboard Cite

In addition to scientific questions, clinical trialists often explore or require other design features, such as increasing the power while controlling the type I error rate, minimizing unnecessary exposure to inferior treatments, and comparing multiple treatments in one clinical trial. We propose implementing adaptive seamless design (ASD) with response adaptive randomization (RAR) to satisfy various clinical trials’ design objectives. However, the combination of ASD and RAR poses a challenge in controlling the type I error rate. In this paper, we investigated how to utilize the advantages of the two adaptive methods and control the type I error rate. We offered the theoretical foundation for this procedure. Numerical studies demonstrated that our methods could achieve efficient and ethical objectives while controlling the type I error rate.

show abstract

“…In cases without relapse or death, the last registration date in the medical record was used. Follow‐up was censored at 60 months 12 . These analyses were performed in R using package survival .…”

Section: Methodsmentioning

confidence: 99%

ALCAM is a biomarker of tumor aggressiveness and worse prognosis in glottic laryngeal squamous cell carcinoma

Nicolau‐Neto,

Peryassú,

de Carvalho

et al. 2024

Head & Neck

View full text Add to dashboard Cite

BackgroundLaryngeal squamous cell carcinoma (LSCC) is the second most frequent head and neck tumor. Prognosis of patients with LSCC has not improved in recent decades, showing a need for the identification of prognostic biomarkers and new therapeutic targets. Recently, we showed that ALCAM overexpression was associated with glottic LSCC prognosis.Objectives and methodsAiming to validate the prognostic value of ALCAM, we evaluate the ALCAM protein levels by immunohistochemistry in 263 glottic LSCC surgically treated with neck dissection.ResultsALCAM was expressed in 48.7% and overexpressed in 36.5% of glottic LSCC samples. ALCAM overexpression was associated with lymph node metastasis (p = 0.030), lymphovascular involvement (p = 0.0002), high‐grade tumors (p = 0.025), and tumor relapse (p = 0.043). Multivariate survival analyses showed an overfitting between ALCAM overexpression and lymph node metastasis as a prognostic variable.ConclusionsHigh ALCAM expression was associated with an aggressive glottic LSCC profile.

show abstract

Clinical Trial Designs in Oncology

Cited by 6 publications

References 119 publications

Outcomes of Laparoscopic Total Gastrectomy Combined With Spleen-Preserving Hilar Lymphadenectomy for Locally Advanced Proximal Gastric Cancer

Outcomes of Laparoscopic Total Gastrectomy Combined With Spleen-Preserving Hilar Lymphadenectomy for Locally Advanced Proximal Gastric Cancer

Seamless Clinical Trials with Doubly Adaptive Biased Coin Designs

ALCAM is a biomarker of tumor aggressiveness and worse prognosis in glottic laryngeal squamous cell carcinoma

Contact Info

Product

Resources

About