Preoperative Therapy for Stomach Cancer
(TOPGEAR Trial)

Recruiting in Palo Alto (17 mi)

+59 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Australasian Gastro-Intestinal Trials Group

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Gastric cancer remains a significant global public health problem. Although in developed countries its incidence has dramatically decreased, on a worldwide scale it is still a leading cause of cancer-related deaths. Surgery is the only potentially curative treatment for gastric cancer. Although the survival rates for patients with early stage disease (stage 1A and 1B) are good, this subgroup of patients constitutes only 20% of those undergoing resection. The majority of patients will have locally advanced or metastatic disease at presentation, which has an extremely poor prognosis. The current five-year survival rate for gastric cancer in Western countries is approximately 20-30%, a figure that has improved little over the past 30 years. The intervention arm in TOPGEAR consists of pre-operative chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy. The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric cancer.

Eligibility Criteria

This trial is for adults over 18 with certain stages of stomach cancer (Stage IB-III) that can potentially be removed by surgery. Participants must have a good performance status, meaning they're able to carry out daily activities with minimal assistance. They need normal blood counts and liver function, adequate kidney function, and if there's a history of heart disease or they are over 60, their heart pumping function needs to be confirmed as sufficient.

Inclusion Criteria

My cancer is between stage IB (only T1N1) and IIIC according to AJCC 7th edition.

My liver tests are within the required range.

Bone marrow: Haemoglobin >=90 g/L, Absolute neutrophil count (ANC) >=1.5 x 10⁹ /L, White blood cell count >=3 x 10⁹ /L, Platelet count >=100 x 10⁹ /L

+7 more

Participant Groups

The TOPGEAR trial is testing whether adding chemoradiotherapy (a combination of chemotherapy drugs and radiation therapy) before surgery improves outcomes compared to just chemotherapy before surgery in patients with resectable gastric cancer. After the initial treatments, all patients will undergo surgery followed by more chemotherapy.

2Treatment groups

Experimental Treatment

Active Control

Group I: Preoperative chemoradiotherapyExperimental Treatment3 Interventions

2 cycles preoperative chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine). OR epirubicin + oxaliplatin + capecitabine OR 3 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel 5 weeks preoperative chemoradiotherapy. Gastric resection. 3 cycles adjuvant chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine). OR epirubicin + oxaliplatin + capecitabine OR 4 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel

Group II: Preoperative chemotherapyActive Control2 Interventions

3 cycles preoperative chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine). OR epirubicin + oxaliplatin + capecitabine OR 4 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel Gastric resection. 3 cycles adjuvant chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine) OR epirubicin + oxaliplatin + capecitabine OR 4 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel