Phase II Study of DC Versus 5-FU/CF as Chemotherapy and Concurrent Chemoradiotherapy for Locally Advanced Gastric Cancer

NCT01889303 | Unknown Phase 2

• 1 other identifier: HCCSC G-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Concurrent chemoradiotherapy has been demonstrated a significant improvement in overall survival and disease-free survival according to Intergroup Trial 0116 in patients with gastric cancer after surgical resection. However,there are still many patients experiencing local recurrence or distant metastasis after adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer after resection. The optimal and standard regimen for adjuvant treatment has not been established in locally advanced gastric cancer yet.The investigators designed the trial to investigate the efficacy and safety of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical resection.

Conditions

Gastric Cancer

Keywords

concurrent chemoradiotherapy; FOLFOX6; chemotherapy; docetaxel; cisplatin; gastric cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as 2 or 3 year disease free survival

  2,3 year

Secondary Outcomes (3)

• Overall survival(OS)

  3 year

• Local and regional control rate

  2,3 year

• feasibility (including adverse events )

  3year

Study Arms (2)

Arm A

ACTIVE COMPARATOR

chemotherapy regimen:Oxaliplatin 85mg/m2 IV d1,Leucovorin 400mg/m2 IV d1,5-FU 400mg/m2 IV bolus d1 ,then 2400mg/m2 over 46h continuous infusion Q2W for 3 cycles → 5-FU 400 mg/m2 IV and Leucovorin 20 mg/m2 IV on the first four and the last three days of radiotherapy + RT 45Gy (5weeks)→ Rest for 4 weeks →Oxaliplatin 85mg/m2 IV d1,Leucovorin 400mg/m2 IV d1,5-FU 400mg/m2 IV bolus d1 ,then 2400mg/m2 over 46h continuous infusion Q2W for 3 cycles. Radiation: concurrent chemoradiotherapy with 5-FU/CF.Radiotherapy consisted of 45Gy of radiation at 1.8Gy per day, five days per week for five weeks.

Drug: concurrent chemoradiotherapy with 5-FU/CF; Radiation: radiation

Arm B

EXPERIMENTAL

chemotherapy regimen:Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W x 2 cycles → Docetaxel 35mg iv D1,Cisplatin 25mg iv D1,QWx4 cycles(but rest in the 4th week during RT) + RT 45Gy (5weeks) for concurrent chemoradiotherapy→ Rest for 4 weeks → Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W x 2 cycles Radiation: concurrent chemoradiotherapy with DC.Radiotherapy consisted of 45Gy of radiation at 1.8Gy per day, five days per week for five weeks.

Drug: DC; Radiation: radiation

Interventions

DC DRUG

Docetaxel plus cisplatin chemotherapy regimen was delivered as chemotherapy and concurrent chemoradiotherapy. chemotherapy regimen: Docetaxel（Qilu Pharma. China） 75mg iv D1, Cisplatin（Qilu Pharma. China） 75mg iv D1 ,Q3W for 2 cycles, then Docetaxel 35mg iv D1, Cisplatin 25mg iv D1,QWx4 cycles(but rest in the 4th week during RT) + RT 45Gy( 5weeks) for concurrent chemoradiotherapy→ Rest for 4 weeks → Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W for 2 cycles.

Also known as: Docetaxel Injection， Hengrui Medicine

Arm B

concurrent chemoradiotherapy with 5-FU/CF DRUG

FOLFOX6 regiment was delivered as adjuvant chemotherapy and 5-FU/CF as concurrent chemotherapy treatment. Adjuvant chemotherapy: FOLFOX6 regiment : Oxaliplatin（Hengrui Medicine Co., Ltd，China） 85mg/m2 IV d1, Leucovorin （Hengrui Medicine Co., Ltd，China）400mg/m2 IV d1, 5-FU（Hengrui Medicine Co., Ltd，China） 400mg/m2 IV bolus d1, followed with 2400mg/m2 over 46h continuous infusion Q2Wx3 cycles of chemotherapy Concurrent chemotherapy : 5-FU 400mg/m2 IV and Leucovorin 20mg/m2 IV were given on the first four and the last three days in the period of radiotherapy. After radiation, patients will have a rest lasting for 4 weeks and then given Folxof6 regiment chemotherapy for 3 cycles.

Also known as: Hengrui Medicine

Arm A

radiation RADIATION

Therapy plan system was formulated by CT simulation. Radiation was delivered with 15MV photons in both Arm A and Arm B. Radiotherapy consisted of 45Gy of radiation at 1.8Gy/day, five days per week for 5 weeks, to the tumor bed, to the margins of resection, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.

Arm A; Arm B

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age \> 19
• Histologically proven gastric or gastroesophageal adenocarcinoma
• ≥ D2 lymph node dissection, curative gastrectomy,
• Stage T4 with or without any positive LN (AJCC 2010) ，No distant metastasis(M0) and after D2 radical gastrectomy
• KPS≥70 or ECOG 0-2
• R0 resection,
• Adequate bone marrow functions (WBC≥4.0×109/L，GRAN≥2.0×109/L，Hb≥90g/L, transfusion allowed, PLT≥100×109/L )
• No severe functional damage of major organ,and no uncontrolled or severe cardiopulmonary concurrent system disease
• Adequate renal functions(serum creatinine ≤ 1.5×ULN ) ;liver functions (serum bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.5 times(normal value) ,serum AKP≤2.5×ULN
• Predictive survival time longer than 6 months.

You may not qualify if:

• pregnant or breast-feeding women;
• Have received preoperative neoadjuvant therapy of gastric cancer
• Before or at the same time with other malignant tumor, and underwent chemotherapy, immune, and biological treatment and radiation therapy;with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
• uncontrolled mental disease
• Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, no myocardial infarction within the last 12 months, unstable angina pectoris, or significant arrhythmia)
• Active infection requiring antibiotics
• Resection margin (+) at permanent pathology
• Peripheral neuropathy symptoms, NCI class \> 1
• severe malnutrition or severe anemia
• uncontrolled Primary brain tumors or the central nervous system disease
• Known hypersensitivity against any of the study drugs
• Pathologic stage I-IIa or IV (according to AJCC 2010)
• Inadequate surgery including D0, D1 resection, dissected LNs less than 12
• Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Chemoradiotherapy; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Physical Phenomena

Study Officials

• Y F Zhou, PHD

  President of Zhongnan Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

F X Zhou, PHD

CONTACT

86-27-67813155; happyzhoufx@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of the department of Radiation and medical oncology

Study Record Dates

• First Submitted: June 2, 2013
• First Posted: June 28, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 14, 2022

Record last verified: 2022-01

Locations

CN (1)