Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prospective Randomized Trial Comparing Gastrectomy, Metastasectomy Plus Systemic Therapy Versus Systemic Therapy Alone: GYMSSA Trial
Brief Summary: Background:

* Gastric (stomach) cancer is a rare cancer. In most cases, by the time it has been diagnosed it has spread to other organs in the body and the chance of a cure is very small. The standard treatment for gastric cancer is a combination of chemotherapy drugs.
* Researchers are interested in finding out if surgically removing all tumors before beginning chemotherapy for stomach cancer can slow or halt its spread better than giving chemotherapy alone.

Objectives:

- To determine whether tumor removal surgery followed by chemotherapy is more effective in treating gastric cancer than chemotherapy given alone.

Eligibility:

- Patients 18 years of age and older who have been diagnosed with gastric cancer.

Design:

* All patients will undergo an initial physical examination, blood tests, imaging scans, and a laparoscopy to determine the extent of the disease.
* Half of the participants will be assigned to have surgery first and then chemotherapy; the other half will be assigned to have chemotherapy alone.

  * The surgery-plus-chemotherapy group will have major surgery to remove all tumors in the stomach and abdominal area, followed by a recovery time of up to 4 weeks. Chemotherapy will begin 6 to 8 weeks after surgery.
  * The chemotherapy-only group will begin treatment within 2 weeks of laparoscopy.
* All patients will receive four chemotherapy drugs: 5-Fluorouracil, leucovorin, oxaliplatin, and irinotecan. The drugs are given intravenously over 2 days every 2 weeks (one cycle) for 12 cycles (about 6 months), either at the National Institutes of Health (NIH) Clinical Center or at home with a referring oncologist. Patients in the surgery group who have tumors in the peritoneum will receive an additional set of chemotherapy drugs in a separate treatment.
* During the chemotherapy cycles, patients will provide blood samples approximately once a week and will have physical examinations and scans on a regular basis.
* Patients will return to the NIH Clinical Center for follow-up visits about every 4 months for 2 years, then every 6 months for 3 years and yearly thereafter.


Options:
A: Arm Label: Arm A (ECF + cetuximab); Type: EXPERIMENTAL; Interventions: Biological: cetuximab, Drug: ECF | Arm Label: Arm B (IC + cetuximab); Type: EXPERIMENTAL; Interventions: Biological: cetuximab, Drug: IC | Arm Label: ARM C (FOLFOX + cetuximab); Type: EXPERIMENTAL; Interventions: Biological: cetuximab, Drug: FOLFOX | Intervention Type: BIOLOGICAL; Name: cetuximab; Assigned to Arm(s): ARM C (FOLFOX + cetuximab), Arm A (ECF + cetuximab), Arm B (IC + cetuximab) | Intervention Type: DRUG; Name: ECF; Assigned to Arm(s): Arm A (ECF + cetuximab) | Intervention Type: DRUG; Name: IC; Assigned to Arm(s): Arm B (IC + cetuximab) | Intervention Type: DRUG; Name: FOLFOX; Assigned to Arm(s): ARM C (FOLFOX + cetuximab)
B: Arm Label: Surgery + HIPEC + Systemic Chemotherapy; Type: EXPERIMENTAL; Interventions: Drug: Oxaliplatin, Drug: Irinotecan, Drug: 5-Fluorouracil, Drug: Leucovorin, Procedure: Gastrectomy and/or metastasectomy | Arm Label: Systemic Chemotherapy Alone; Type: EXPERIMENTAL; Interventions: Drug: Oxaliplatin, Drug: Irinotecan, Drug: 5-Fluorouracil, Drug: Leucovorin | Intervention Type: DRUG; Name: Oxaliplatin; Assigned to Arm(s): Surgery + HIPEC + Systemic Chemotherapy, Systemic Chemotherapy Alone | Intervention Type: DRUG; Name: Irinotecan; Assigned to Arm(s): Surgery + HIPEC + Systemic Chemotherapy, Systemic Chemotherapy Alone | Intervention Type: DRUG; Name: 5-Fluorouracil; Assigned to Arm(s): Surgery + HIPEC + Systemic Chemotherapy, Systemic Chemotherapy Alone | Intervention Type: DRUG; Name: Leucovorin; Assigned to Arm(s): Surgery + HIPEC + Systemic Chemotherapy, Systemic Chemotherapy Alone | Intervention Type: PROCEDURE; Name: Gastrectomy and/or metastasectomy; Assigned to Arm(s): Surgery + HIPEC + Systemic Chemotherapy
C: Arm Label: S-1 plus cisplatin; Type: EXPERIMENTAL; Interventions: Drug: s-1 plus cisplatin | Arm Label: 5-Fu plus cisplatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: 5-Fu plus cisplatin | Intervention Type: DRUG; Name: s-1 plus cisplatin; Assigned to Arm(s): S-1 plus cisplatin | Intervention Type: DRUG; Name: 5-Fu plus cisplatin; Assigned to Arm(s): 5-Fu plus cisplatin
D: Arm Label: A1: Surveillance; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm A2: Capecitabine Maintenance; Type: EXPERIMENTAL; Interventions: Drug: Capecitabine | Arm Label: Arm A3: MEDI4736 (Durvalumab); Type: EXPERIMENTAL; Interventions: Drug: MEDI4736 (Durvalumab) | Arm Label: Arm B1: Trastuzumab Maintenance; Type: ACTIVE_COMPARATOR; Interventions: Drug: Trastuzumab | Arm Label: Arm A4: Rucaparib; Type: EXPERIMENTAL; Interventions: Drug: Rucaparib | Arm Label: Arm A5: Capecitabine and Ramucirumab; Type: EXPERIMENTAL; Interventions: Drug: Capecitabine, Drug: Ramucirumab | Intervention Type: DRUG; Name: Capecitabine; Assigned to Arm(s): Arm A2: Capecitabine Maintenance, Arm A5: Capecitabine and Ramucirumab | Intervention Type: DRUG; Name: MEDI4736 (Durvalumab); Assigned to Arm(s): Arm A3: MEDI4736 (Durvalumab) | Intervention Type: DRUG; Name: Trastuzumab; Assigned to Arm(s): Arm B1: Trastuzumab Maintenance | Intervention Type: DRUG; Name: Rucaparib; Assigned to Arm(s): Arm A4: Rucaparib | Intervention Type: DRUG; Name: Ramucirumab; Assigned to Arm(s): Arm A5: Capecitabine and Ramucirumab

Answer: B