The NICO Phase II clinical trial – Focus on an emerging immunotherapy strategy for the adjuvant treatment of locally advanced oral cancers

TPS4167 Background: There is growing consensus for the use of neoadjuvant therapy in patients with potentially operable pancreatic adenocarcinoma (PC). However, there is not consensus on the type and duration of chemotherapy or radiation therapy (RT) dose. Stereotactic body radiation therapy (SBRT) has gained popularity despite the absence of prospective data for its use in the preoperative setting. Furthermore, SBRT preoperatively has not been standardized. At present, there exists no randomized data comparing preoperative SBRT with conventionally fractionated concurrent chemo-RT. We designed this trial to examine differences between pre-op RT dose and fractionation schedules. Methods: This study is a prospective, randomized, two-arm, phase II clinical trial. Eligible patients must have cytologically confirmed PC and be deemed suitable for surgical resection with resectable, borderline resectable, or locally advanced type A disease, based on cross-sectional imaging. Before randomization patients are stratified by clinical node positivity, neoadjuvant chemotherapy, and stage of disease. Patients are then randomized to either 50.4 Gy over 28 fractions with concurrent weekly Gemcitabine vs SBRT to a total dose of 25-35 Gy over 5 fractions. The primary endpoint of the study is pathologic node positivity. We hypothesize that patients treated with neoadjuvant chemotherapy followed by conventionally fractionated chemo-RT will have a lower rate of pathologic node positivity as compared to those patients treated with neoadjuvant chemotherapy followed by SBRT. Secondary endpoints include patient reported quality of life, local recurrence, primary tumor pathologic response, margin status, surgical complications, MR based treatment response, and overall survival. We anticipate a node positivity rate of 37% when using preoperative chemotherapy followed by SBRT. We hypothesize that treatment with chemotherapy followed by conventionally fractionated chemo-RT will reduce the rate of node positivity to 17%. Using a one-sided Type I error rate of 0.1, approximately 88 total patients (44 per arm) provide an 80% power to detect the hypothesized difference in pathologic node positivity between the two arms. To address patient dropout, an additional 14 patients (about 15%) will be enrolled for a total target accrual of 102 patients. The trial opened in November 2018 and 8 of the planned 102 patients have been enrolled. Clinical trial information: NCT03704662.

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Phase II clinical trial using novel peptide cocktail vaccine as a postoperative adjuvant treatment for surgically resected pancreatic cancer patients

International Journal of Cancer ◽

10.1002/ijc.30510 ◽

2016 ◽

Vol 140 (4) ◽

pp. 973-982 ◽

Cited By ~ 22

Author(s):

Motoki Miyazawa ◽

Masahiro Katsuda ◽

Hiroyuki Maguchi ◽

Akio Katanuma ◽

Hiroshi Ishii ◽

...

Keyword(s):

Pancreatic Cancer ◽

Clinical Trial ◽

Cancer Patients ◽

Phase Ii ◽

Adjuvant Treatment ◽

Phase Ii Clinical Trial ◽

Postoperative Adjuvant Treatment

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Phase II clinical trial preliminary report: Cetuximab, gemcitabine and simultaneous radiotherapy for locally advanced head and neck cancer: Preliminary report

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.15502 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 15502-15502

Author(s):

J. G. De La Garza ◽

M. Granados ◽

J. L. Aguilar ◽

J. Lavin ◽

G. Cabrera ◽

...

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Preliminary Report ◽

Tumor Staging ◽

Locally Advanced ◽

Previous Treatment ◽

Phase Ii Clinical Trial ◽

Statistical Validation ◽

Informed Consent Form

15502 Background: Previous studies with cetuximab in SCCHN demonstrate to be clinically beneficial. In the present study we wished to evaluate the efficacy and safety of a chemotherapeutic scheme using gemcitabine, radiotherapy and cetuximab for SCCHN. Preliminary report of 20 of 40 enrolled patients into a phase II clinical trial. Methods: inclusion criteria; histological confirmation of epidermoid carcinoma, ages 18 to 70, K > 70%, normal renal, hepatic and haematologic functions, without previous treatment, surgically inoperable disease, or patients with operable disease that did not consent to surgery. All patients signed an informed consent form. Radiotherapy: 200 cGy/d/5/w until 70Gy were completed. Cetuximab: an initial dose of 400 mg/m2 one week prior to initiation of radiotherapy, followed by 250 mg/m2 weekly until completion of radiotherapy. Gemcitabine: 50 mg /m2 weeks 1–2, 4–5 and 7. Results: 20 patients were enrolled (16m/4f) from november of 2004 to november of 2005, (5 oral cavity, 5 oropharynx, 8 larynx, 1 hypopharynx and 1 paranasal sinus). Mean age 56 yrs (33–75). Tumor staging: 7/III, 8/IVa and 5/IVb. One female was excluded, 19 completed the study and were evaluated. GR 17/19 (89.5%), CR 13/17 (76.5%) and PR 4/17 (23.5%). 2/19 NR (10.5%). CR of the 1ary tumor 15/19 patients (78.9%); CR 6/11 patients with lymphatic disease at diagnosis (54.5%), PR 3/19 (27.3%). Toxicity: mucositis g/III-IV 8/19 patients; rash g/III 4 patients. 2/19 did not complete treatment with chemotherapy due to mucositis but did with radiotherapy. No relationship was found between clinical response and the severity of the rash. One patient developed leukopenia g/III. 4 patients developed disphagia g/II, one has not resolved after 8 month follow up. Xerostomia g/II was 7/19 patients. Dermatological toxicity resolved by the end of the treatment. Mean follow up: 6 months, 1 patient which did not respond died and 1 patient with a PR recurred. Conclusions: The scheme is safe and effective with tolerable toxicity. In our previously reported experience, the addition of cetuximab to gemcitabine and radiotherapy does not increment local toxicity, statistical validation of these findings require the completion of the 40 patient study. No significant financial relationships to disclose.

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