Docetaxel-based Chemoradiotherapy Plus Periradiation Chemotherapy Compared With INT 0116 Adjuvant Arm in Gastric Cancer

NCT02640898 | Unknown DMC

• 1 other identifier: SGH201510
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Although the intergroup 0116 trial was the first to demonstrate that adjuvant chemoradiotherapy offers a significant survival benefit in completely resected gastric cancer,it is more toxic and less effective. It is reasonable to optimize this regimen.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival rate

  survival time was measured from the date of study enrollment to the date of death or last follow-up

  3-year (36-month)

Secondary Outcomes (1)

• progression free survival rate

  3-year (36-month)

Study Arms (2)

FU-based chemoradiotherapy

ACTIVE COMPARATOR

patients will be treated with the INT0116 regimen.

Radiation: FU-based chemoradiotherapy

docetaxel-based chemoradiotherapy

EXPERIMENTAL

patients will be treated with modified DCF chemotherapy in combination with docetaxel-based chemoradiotherapy.

Radiation: docetaxel-based chemoradiotherapy

Interventions

docetaxel-based chemoradiotherapy RADIATION

experimental:Patients with Zubrod performance status (PS) of 0-2 received up to 2 21-day cycles of pre- and post-radiation chemotherapy (docetaxel 37.5 mg/m2 on days 1 and 8, cisplatin 25 mg/m2 on days 1-3, and a continuous infusion of fluorouracil (FU) 750 mg/m2 on days 1-5), respectively. CCRT between pre- and post-radiation chemotherapy was initiated on day 43 and consisted of 3-dimensional conformal intensity-modulated radiation therapy (45 Gy) plus concurrent docetaxel 20 mg/m2 weekly for 6 weeks;

Also known as: a docetaxel arm

docetaxel-based chemoradiotherapy

FU-based chemoradiotherapy RADIATION

The adjuvant treatment consisted of 425mg/m2 of bolus fluorouracil(5-FU) per day, 20 mg/m2 of leucovorin (LV), per day, for 5 days, followed by 45Gy of radiation with current 5-FU ( 400mg/m2 ) and LV (20mg/m2) as an intravenous bolus on each of of the first four days and the last three days of irradiation. One month after the completion of radiotherapy, two 5-day cycles of 5-FU and FV chemotherapy were given one month apart.

Also known as: the INT 0116 adjuvant arm

FU-based chemoradiotherapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with microscopically confirmed stages IB through IIIB adenocarcinoma of the stomach or gastroesophageal junction, who underwent a potentially curative resection (ie, R0 resection);
• Zubrod performance status 0 to 1;
• No prior chemotherapy or prior radiation therapy to the treatment field;
• Age 20-75;
• Absolute granulocyte count (AGC) ≥2 × 109 cells/L, platelets ≥ 100× 109 cells/L, hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable)
• Adequate renal and hepatic function (serum creatinine ≤1.5 × upper limit of normal \[ULN\], bilirubin and AST ≤1.5 × ULN).

You may not qualify if:

• A history of prior upper abdominal radiotherapy or chemotherapy;
• Evidence of metastatic disease to distant organs, peritoneal carcinoma by computed tomography or positive cytology of peritoneal effusion;
• Prior malignancies (except cured cervical carcinoma in situ, non-melanoma skin cancer, or other curatively treated cancer with no evidence of disease for ≥5 years);
• active inflammatory bowel disease;
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
• Transmural myocardial infarction within the last 6 months;
• uncontrolled hypertension;
• Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 60 days before registration;
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
• Patients with Acquired Immune Deficiency Syndrome were excluded from the study because the treatments involved in this protocol may be significantly immunosuppressive.
• Hypersensitivity reaction to docetaxel;
• Uncontrolled neuropathy grade 2 or greater regardless of cause;
• Conditions precluding medical follow-up and protocol compliance;
• Pregnant or lactating women are excluded from study entry due to the embryotoxic effects of the protocol treatment.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

the Ethic Committee of Shanghai General Hospital

Shanghai, Shanghai Municipality, 210000, China

RECRUITING

Related Publications (6)

• Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.

  PMID: 11547741 BACKGROUND

• Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.

  PMID: 16822992 BACKGROUND

• Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J. Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer. 1994 Aug;70(2):380-3. doi: 10.1038/bjc.1994.310.

  PMID: 7914428 BACKGROUND

• Choy H, Rodriguez FF, Koester S, Hilsenbeck S, Von Hoff DD. Investigation of taxol as a potential radiation sensitizer. Cancer. 1993 Jun 1;71(11):3774-8. doi: 10.1002/1097-0142(19930601)71:113.0.co;2-0.

  PMID: 8098270 BACKGROUND

• Mauer AM, Masters GA, Haraf DJ, Hoffman PC, Watson SM, Golomb HM, Vokes EE. Phase I study of docetaxel with concomitant thoracic radiation therapy. J Clin Oncol. 1998 Jan;16(1):159-64. doi: 10.1200/JCO.1998.16.1.159.

  PMID: 9440738 BACKGROUND

• Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006 Nov 1;24(31):4991-7. doi: 10.1200/JCO.2006.06.8429.

  PMID: 17075117 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• tingfeng chen, MD

  the ethic committee of shanghai genernal hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yong liu, MD

CONTACT

37798364; drliuyrt@163.com

tiening zhang, MD

CONTACT

37798364; tiening69@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docetaxel-based chemoradiotherapy plus periradiation chemotherapy in R0 gastric cancer

Study Record Dates

• First Submitted: December 19, 2015
• First Posted: December 29, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)