SWOG clinical trial number
S1600

A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

Open
Phase
III
Accrual
4%
Abbreviated Title
Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Status Notes
This study is open effective February 21, 2019 at 2:00 p.m. Eastern.
Activated
02/21/2019
Participants
ALLIANCE, ECOG-ACRIN, NRG, SWOG

Research committees

Symptom Control and Quality of Life
Genitourinary Cancer

Treatment

Placebo Immune-modulating drink

Other Study Materials

Eligibility Criteria Expand/Collapse

Tissue diagnosis of primary cell carcinoma of the bladder by TURBT or partial cystectomy. No evidence of unresectable disease or metastatic disease as assessed by exam under anesthesia or imaging (CT, MRI, PET). Plans for the cystectomy to be performed within 28 calendar days after registration. Surgery must be planned to be performed under pre-approved, study-specific surgical guidelines (see Section 7.3). Must have completed any neoadjuvant chemotherapy or immunotherapy (intravesical or systemic) >/= 14 calendar days prior to registration and any toxicities resolved to at least Grade 2. May have a history of radiation therapy. Radiation therapy must have been completed >/= 180 days prior to registration. May have a history of prior partial cystectomy. Prior partial cystectomy must have been completed at least 180 days prior to registration. Must not have planned adjuvant chemotherapy within 90 days after radical cystectomy. >/= 18 years of age. Must be able to swallow liquid and have no refractory nausea, vomiting, malabsorption, or significant small bowel resection that would preclude adequate absorption. Patients on tube feeding are not eligible. Must have baseline nutrition status assessed using the Scored Patient-Generated Subjective Global Assessment (PG-SGA) by a clinician or licensed healthcare practitioner within 14 days prior to registration and must not have a global category rating of Stage C (severely malnourished). Must not have galactosemia. Must not have known active viral infections such as human immunodeficiency virus (HIV) or hepatitis, as these chronic viral infections may cause cachexia and immunodeficiency and thus alter the biology regarding the study endpoints. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years. Prostate cancer found at cystectomy would not be considered a prior malignancy. Must not be pregnant or nursing as the conditions preclude candidacy for radical cystectomy. Must consent and be willing to have specimens collected and submitted as described in Section 15.1. Must consent and provide their telephone contact information for four 24-hour dietary recall phone interviews to be conducted by staff at the Exercise, Diet, Genitourinary, & Endocrinology Laboratory (EDGE) Research Laboratory (see Sections 7.1c, 7.7e, and 15.3). Must be able to understand and speak English because the dietary recall phone interviews will only be conducted in English.

Publication Information Expand/Collapse

2018

A Randomized Phase III Double-Blind Clinical Trial (S1600) Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

J Hamilton-Reeves;J Holzbeierlein;J Unger;D Lew;M Fisch;NL Henry J Clin Oncol 36(suppl 6S; abstr TPS529); ASCO GU Symposium (February 8-10, 2018, San Francisco), poster, abst TPS529

Reports & Approvals

Trial Locations

Other Clinical Trials

SWOG Clinical Trial Number
SWOG-7303
SWOG Clinical Trial Number
SWOG-8221 (INT-0007)

Treatment of Advanced Bladder Cancer with Preoperative Irradiation and Radical Cystectomy versus Radical Cystectomy Alone

Research Committee(s)
Genitourinary Cancer
Activated
10/29/1982
Closed
11/15/1989
Accrual
81%
Closed
Published
SWOG Clinical Trial Number
SWOG-8216/38

Comparison of BCG Immunotherapy and Adriamycin for Superficial Bladder Cancer

Research Committee(s)
Genitourinary Cancer
Activated
12/01/1982
Closed
01/15/1987
Closed
Phase
III
Published