Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 3; Phase 2

Conditions: Esophagus Cancer; Chemoradiation; Radiotherapy; Complications; Esophagogastric Junction Cancer

Treatments: Drug: S-1; Radiation: SIB-IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02979691

3JECROG P-01

Details and patient eligibility

About

Ratiotherapy alone is the current standard treatment for elderly esophageal or esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly patients. This study aimed to assess the efficiency and safety of simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric cancer patients

Enrollment: 350 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥70 years
• Esophageal or Esophagogastric cancer
• Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as IIa-IVb (UICC 2002, IVb only with supraclavicular or celiac trunk lymph nodes metastasis)
• Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
• No distant metastasis other than supraclavicular lymph nodes
• No prior history of thoracic radiation
• Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
• Informed consent

Exclusion criteria

• Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
• With any distant metastasis out of regional lymphatic drainage or in liver,lung,bone,CNS,etc
• History of allergic reactions attributed to similar chemical or biologic complex to S-1
• With esophageal fistula, perforation, cachexia prior to treatment
• Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
• History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
• Pregnant or lactating females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

350 participants in 2 patient groups

SIB-IMRT

Active Comparator group

Description:

SIB-IMRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday).

Treatment:

Radiation: SIB-IMRT

S1 based SIB-IMRT

Experimental group

Description:

S1 based SIB-IMRT receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday) followed by four cycles of S-1 (40-60mg, orally twice daily, d1-14, every 3 weeks) as an adjuvant chemotherapy.

Treatment:

Drug: S-1

Radiation: SIB-IMRT