A multicenter phase III study comparing Simultaneous Integrated Boost (SIB) radiotherapy concurrent and consolidated with S-1 versus SIB alone in elderly patients with esophageal and esophagogastric cancer - the 3JECROG P-01 study protocol.

Abstract

BACKGROUND:

The importance of definitive radiotherapy for elderly patients with esophageal and esophagogastric-junction cancer is pronounced. However, little is known in terms of the best way to combine radiotherapy with other treatment options. This study aims to compare the efficiency of SIB radiotherapy alone with SIB radiotherapy concurrent and consolidated with S-1 for elderly patients. Comprehensive geriatric assessment is also incorporated in the procedure of treatment.

METHODS/DESIGN:

The study is a two arm, open, randomized multicenter Phase III trial with patients over 70 years old with stage IIA-IVB (UICC 2002, IVB only with metastasis to supraclavicular or celiac lymph nodes) squamous cell carcinoma or adenocarcinoma of esophagus or gastroesophageal junction. A total of 300 patients will be randomized using a 1:1 allocation ratio stratified by disease stage and study site. Patients allocated to the SIB arm will receive definitive SIB radiotherapy (95%PTV/PGTV 50.4Gy/59.92Gy/28f) while those randomized to SIB + S-1 arm will receive definitive SIB radiotherapy concurrent and consolidated with S-1. The primary endpoint of the trial is 1-year overall survival. Secondary objectives include progression-free survival, recurrence-free survival (local-regional and distant), disease failure pattern, toxicity profile as well as quality of life. Besides, detailed radiotherapy protocol and quality assurance procedure have been incorporated into this trial.

DISCUSSION:

The proportion of elderly patients in esophageal cancer is now growing, but there is a lack of evidence in term of treatment standard for this group of patients, which is what we aim to obtain through this prospective phase III study.

TRIAL REGISTRATION:

clinicaltrials.gov NCT02979691 . Registered November 22, 2016.

• Authors: Chen Li, Xiaomin Wang, Xin Wang, Chun Han, Ping Wang, Qingsong Pang, Junqiang Chen, Xinchen Sun, Lan Wang, Wencheng Zhang, Yu Lin, Xiaolin Ge, Zongmei Zhou, Wenjie Ni, Xiao Chang, Jun Liang, Lei Deng, Wenqing Wang, Yidian Zhao, Zefen Xiao
• Journal: BMC cancer (BMC Cancer) Vol. 19 Issue 1 Pg. 397 (Apr 29 2019) ISSN: 1471-2407 [Electronic] England
• PMID: 31036088 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Drug Combinations
• S 1 (combination)
• Tegafur
• Oxonic Acid
• Fluorouracil

Topics

• Adenocarcinoma (pathology, therapy)
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (pathology, therapy)
• Chemoradiotherapy
• Drug Combinations
• Esophageal Neoplasms (pathology, therapy)
• Esophagogastric Junction (drug effects, pathology, radiation effects)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Humans
• Male
• Neoplasm Staging
• Outcome Assessment, Health Care (methods, statistics & numerical data)
• Oxonic Acid (administration & dosage, adverse effects)
• Prospective Studies
• Radiotherapy, Intensity-Modulated (adverse effects, methods)
• Stomach Neoplasms (pathology, therapy)
• Tegafur (administration & dosage, adverse effects)