scholarly journals Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): Study Protocol for a Randomized Phase II Trial

2020 ◽  
Author(s):  
Pencilla Lang ◽  
Jessika Contreras ◽  
Noah Kalman ◽  
Claire Paterson ◽  
Houda Bahig ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Oral Cavity ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Phase Iii ◽  
Oncologic Outcomes ◽  
Adjuvant Radiation ◽  
Nodal Involvement ◽  
Regional Failure

Abstract Background Patients with resected oral cavity squamous cell carcinoma (OCSCC) are often treated with adjuvant radiation (RT) ± concomitant chemotherapy based on pathological findings. Standard RT volumes include all surgically dissected areas, including the tumour bed and dissected neck. RT has significant acute and long-term toxicities including odynophagia, dysphagia, dermatitis and fibrosis. The goal of this study is to assess the rate of regional failure with omission of radiation to the surgically dissected pathologically node negative (pN0) hemi-neck(s) compared to historical control, and to compare oncologic outcomes, toxicity, and quality of life (QoL) profiles between standard RT volumes and omission of RT to the pN0 neck. Methods This is a multicentre phase II study randomizing ninety patients with T1-4 N0-2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). Patients will be stratified based on overall nodal status (nodal involvement vs. no nodal involvement) and use of concurrent chemotherapy. The primary endpoint is regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence of 20% or less will be achieved. Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL. Discussion This study will provide an assessment of omission of RT to the dissected pN0 hemi-neck(s) on oncologic outcomes, QoL and toxicity. Results will inform the design of future definitive phase III trials. Trial Registration: Clinicaltrials.gov identifier: NCT03997643. Date of registration: June 25, 2019, Current version: 2.0 on July 11 2020. URL: https://clinicaltrials.gov/ct2/show/NCT03997643

659 AN SINGLE-ARM OPEN-LABEL PHASE II STUDY OF CAMRELIZUMAB PLUS APATINIB AS SECOND-LINE TREATMENT FOR ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Feng Wang ◽  
Qingxia Fan ◽  
Junsheng Wang ◽  
Tao Wu ◽  
Yonggui Hong ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Objective Response ◽  
Phase Iii ◽  
Line Treatment ◽  
Second Line

Abstract   Esophageal squamous cell carcinoma (ESCC) as a common malignancy is prevalent in East Asia and in eastern and southern Africa. Although pembrolizumab, nivolumab and camrelizumab are respectively recommended as second-line treatment for advanced ESCC due to improved overall survival (OS), objective response rate (ORR) was modest. New effective treatments are needed. Hence, the study of camrelizumab plus apatinib (VEGFR2 inhibitor) as second-line treatment for advanced ESCC was performed. Methods This ongoing phase II trial (NCT03736863) in six sites in China enrolled pts aged 18-75 with unresectable locally advanced, locally recurrent, or metastatic ESCC that progressed or were intolerant after first-line chemotherapy, and an ECOG performance status of 0-1. Pts received 200 mg camrelizumab intravenously every 2 weeks and apatinib 250 mg orally once per day in 4-week cycles until disease progression, unacceptable adverse events (AEs) or withdrawal of consent. The primary endpoint was investigator-assessed ORR. Secondary endpoints included disease control rate (DCR), progression-free survival (PFS) and OS. Results At data cutoff (Feb 28, 2021), 52 pts were enrolled, including 42 males and 50 with distant metastases, with the median age of 62 years. In the evaluable population of 39 pts, ORR without confirmation was 43.59% and DCR was 94.87%. The median duration of response was 6.9 months (95% CI 4.57–9.23). The median PFS was 6.8 month (95% CI 2.66–10.94). The 12-month overall survival was 52.2%. A total of 80.8% of pts had treatment-related AEs (TRAEs) with 46.2% of grade ≥ 3 TRAEs. The safety profile of camrelizumab and apatinib was consistent with other anti–PD-1 antibodies and angiogenesis inhibitors. Conclusion This is the first study that evaluates the combination anti–PD-1 antibody and anti-angiogenesis inhibitor as a second-line therapy for advanced ESCC. Camrelizumab plus apatinib showed encouraging clinical efficacy and acceptable safety. Further phase III randomized trials are warranted.

Neoadjuvant chemoradiotherapy with 5-fluorouracil-cisplatin combined with cetuximab in patients with resectable locally advanced esophageal carcinoma: A prospective phase I/II trial (FFCD-PRODIGE 3)—Preliminary phase II results.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4091-4091
Author(s):  
Laetitia Dahan ◽  
Christophe Mariette ◽  
Marc Ychou ◽  
Tan Dat Nguyen ◽  
Rosine Guimbaud ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Esophageal Cancer ◽  
Phase I ◽  
Cell Carcinoma ◽  
Dose Level ◽  
Phase Ii ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Stage Ii ◽  
Phase Iii

4091 Background: Chemoradiotherapy (CRT) for locally advanced esophageal cancer is based on 5FU combined with cisplatin. The anti-EGFR antibody cetuximab increases the efficacy of RT-based regimen for patients (pts) with cancer of the head and neck. This phase I/II trial was evaluating MTD, safety and pathologic complete response (pCR) rate of the combination of cetuximab with platinum-based CRT in esophageal cancer. Methods: Inclusion criteria: squamous cell carcinoma or adenocarcinoma of the esophagus, stage II-III, WHO PS 0-1. A radiotherapy of 45 grays (1.8 Gy/25F) was given over 5 weeks. During phase I, four patients experienced limited toxicity to dose level 0, and treatment was desescalated to dose level -1: weekly cetuximab (400 mg/m2 one week before start of radiotherapy and 250 mg/m2 during radiotherapy), and 5 FU (500 mg/m2 per day D1-D4) combined with cisplatin (40 mg/m2 D1) on week 1 and 5. Nine pCR over 27 resections were needed to show a pCR rate>20% (α=5%, power = 90% ). Thirty three patients were included in the phase II. Results: From 07-2007 to 01-2011, 33 pts were enrolled, 20 squamous cell carcinoma (60.6%), 13 adenocarcinoma (39.4%), 25 (75.8%) stage III and 8 (24.2%) stage II. Among 32 pts who received CRT, the main grade 3-4 toxicities were esophagitis (4 pts), leucopenia (1 pt), anaphylaxis reaction (1 pt), rash (1 pt). Resection was achieved in 27 pts (25 R0)/31 who underwent surgery. Complete or near complete pathologic response (TRG grades 1 and 2 to Mandard) was achieved respectively in 5 (18.5%) and 6 (22.2%) pts. There were 4 deaths at 30 days post surgery. Severe postoperative complications were pulmonary complications (8), anastomotic stricture (4), gastric necrosis (1) and infection (7). The median overall survival was 15.7 months [11.01-.], and the median relapse free survival was 13.7 months [5.47-.]. Conclusions: Adding cetuximab to preoperative chemoradiotherapy including 5FU and cisplatin did not increase pCR. The recommended dose level of chemotherapy determined during phase I could explain those disappointing results. We won’t initiate a phase III trial.

A multicenter phase II trial of docetaxel, cisplatin and cetuximab (TPE) followed by cetuximab concurrent with radiotherapy in patients with local advanced squamous cell carcinoma of the head and neck (ECRIPS study).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6071-6071 ◽  
Author(s):  
Sadamoto Zenda ◽  
Yosuke Ota ◽  
Naomi Kiyota ◽  
Susumu Okano ◽  
Masato Fujii ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Induction Chemotherapy ◽  
Phase Ii ◽  
Squamous Cell ◽  
Treatment Completion ◽  
Phase Iii ◽  
Advanced Squamous Cell Carcinoma ◽  
Concurrent Radiotherapy

6071 Background: Induction chemotherapy is a treatment option for locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). However, Docetaxel, Cisplatin, and 5-FU (TPF) followed by Cisplatin with radiotherapy is currently not recommended due to toxicity concerns. The aim of this phase II study was to assess the feasibility of Docetaxel, Cisplatin, and Cetuximab (TPE) followed by Cetuximab with concurrent radiotherapy for LA-SCCHN. Methods: Patients were eligible if they had histologically proven SCC of oropharynx, hypopharynx or larynx, a PS of 0-1, adequate organ function, and no distant metastasis. Induction chemotherapy consisted of Cisplatin 75mg/m2 and Docetaxel 75mg/m2 on day1 and the induction regimen was repeated every 3 weeks up to a total of 3 courses. Cetuximab was administered at an initial dose of 400mg/m2 followed by 250mg/m2 weekly until the end of radiotherapy. Radiotherapy (70Gy/35fr/7w) was started after last administration of Docetaxel. Primary endpoint was the rate of treatment completion. The planned sample size was 55 with one-sided alpha of 0.025 and the power of more than 90% based on the expected and threshold treatment completion rates of 65% and 40%. Results: Between August 2013 and October 2015, 54 patients with a median age of 58 years were eligible and had the study treatment. There were 50 males, hypopharynx/oropharynx/larynx cancer of 28/19/7 cases, and 48 Stage IV disease. Response rate at induction chemotherapy was 72% while that after radiotherapy was 76% . Of 54 patients, 50 (93%) received > 2 courses of induction chemotherapy, and 41 (76%) had the full dose of radiotherapy. The rate of treatment completion was thus 76% (95%CI, 62–87%). The frequency of grade 3-4 neutropenia, febrile neutropenia, and allergy/infusion reaction was 93%, 39%, and 11%, respectively. One treatment-related death was observed. Conclusions: Induction TPE followed by Cetuximab with concurrent radiotherapy was feasible with a promising efficacy. A phase III study to evaluate this treatment strategy is warranted. Clinical trial information: UMIN000009928.

scholarly journals The Origin of Regional Failure in Oral Cavity Squamous Cell Carcinoma With Pathologically Negative Neck Metastases

2014 ◽  
Vol 140 (12) ◽  
pp. 1130 ◽  
Author(s):  
Moran Amit ◽  
Tzu Chen Yen ◽  
Chun Ta Liao ◽  
Pankaj Chaturvedi ◽  
Jai Prakash Agarwal ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Oral Cavity ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Neck Metastases ◽  
Regional Failure
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