Perioperative Chemotherapy Combined With HIPEC for High-risk Advanced Gastric Cancer

Survival Clinical Trial

— HIPEC  

Official title:

D2 Radical Resection After Neoadjuvant Chemotherapy Combined With HIPEC for Advanced Gastric Cancer: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02960061
• Other study ID #: HIPEC-006
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 3, 2016
• Last updated: November 8, 2016
• Start date: November 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Hua-She Wang, PhD
• Phone: +8613824468573
• Email: angelwhs[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial Summary

The investigators intend to conduct a randomized controlled study to find if combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection could improve survival for patients with advanced gastric cancer, while comparing with the traditional approach of D2 resection after neoadjuvant chemotherapy.

Description:

Gastric cancer, as the second common malignant tumors in china, is marked by its poor prognosis and high recurrent rate. Although R0 resection could be achieved in most advanced gastric cancer(AGC) patients without metastasis, age-standardized 5-years survival rate was no more than 27.4%. Peritoneal metastasis accounts for 50% of the recurrent case and remain to be the most fatal recurrence pattern.

Hyperthermic intraperitoneal perfusion chemotherapy ( HIPEC ), has been proved as one of the most efficient approach against peritoneal carcinomatosis from gastric cancer and recommended in the guideline for gastric cancer published by the health committee of china. However, its role as prophylactic treatment after curative has never been determined. HIPEC works by delivering heat and cytotoxic drug to the cancer cell and is more effective on the tumor with small size. As present study suggest that Peritoneal metastasis is related to lymph node dissection during surgery while opening lymphatic channels and spreading viable cancer cells into the peritoneal cavity, HIPEC might be a reasonable approach to destroy the remaining cancer cells after curative surgery. Thus this research aim to explore the efficacy and safety of combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 640
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. First diagnosed as gastric cancer by pathological examination;

2. No previous chemotherapy or radiotherapy;

3. T stage:3-4, N stage: 1-3, M stage: 0, assessed by CT or ultrasound endoscope;

4. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-1;

5. Informed consent signed;

Exclusion Criteria:

1. Other malignancy within 5 years.

2. Peritoneal metastasis detected during surgery.

3. Pregnant or lactating women;

4. Patients with conditions requiring emergency surgery;

5. Tumor progress during neo-adjuvant chemotherapy

6. Severe, uncontrolled physical or metal disease.

7. Poor compliance.

8. Uncontrolled infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms
• Survival

Intervention

Drug:
• Neoadjuvant chemotherapy
Eligible patients receive 4 cycles of mDOF(docetaxel 50 mg/ m2 day 1 + oxaliplatin 85 mg/ m2 day 2 + fluorouracil 400 mg/ m2 bolus iv followed by 600 mg/ m2 22 hours chronic infusion, day 2/3 + leucovorin 200 mg/ m2, day2/3; repeated every 14 days ).

Procedure:
• D2 radical resection
Laparotomy or laparoscopic surgery are chosen according to the preference of the surgeon. Either cases, a throughout peritoneal cavity exploration is required to comfirmed the tumor resectability and peritoneal metastasis. A curative D2 resection is performed if achievable.

Drug:
• Hyperthermic intraperitoneal perfusion chemotherapy
Two cycle of hyperthermic intraperitoneal perfusion chemotherapy is administered to patients who have received neoadjuvant chemotherapy and D2 resection, dosage and the relative parameter setting is described above.
• Adjuvant chemotherapy
Adjuvant chemotherapy using SOX or XELOX regimen will be administered as routine within 4-6 weeks.

Locations

Country	Name	City	State
China	The sixth affliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

Hamazoe R, Maeta M, Kaibara N. Intraperitoneal thermochemotherapy for prevention of peritoneal recurrence of gastric cancer. Final results of a randomized controlled study. Cancer. 1994 Apr 15;73(8):2048-52. — View Citation

Lin CH, Hsieh HF, Yu JC, Chen TW, Yu CY, Hsieh CB. Peritoneal lavage with distilled water during liver resection in patients with spontaneously ruptured hepatocellular carcinomas. J Surg Oncol. 2006 Sep 1;94(3):255-6. — View Citation

Marutsuka T, Shimada S, Shiomori K, Hayashi N, Yagi Y, Yamane T, Ogawa M. Mechanisms of peritoneal metastasis after operation for non-serosa-invasive gastric carcinoma: an ultrarapid detection system for intraperitoneal free cancer cells and a prophylactic strategy for peritoneal metastasis. Clin Cancer Res. 2003 Feb;9(2):678-85. — View Citation

Yonemura Y, de Aretxabala X, Fujimura T, Fushida S, Katayama K, Bandou E, Sugiyama K, Kawamura T, Kinoshita K, Endou Y, Sasaki T. Intraoperative chemohyperthermic peritoneal perfusion as an adjuvant to gastric cancer: final results of a randomized control — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of survival participants will be assessed according to the data collected by the followed up office.		1-5 years	Yes
Secondary	Progression Free Survival		1-3 years	Yes