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Report for Clinical Trial NCT02413736

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST With a High Risk for Recurrence: A Randomised Phase III Study

In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST) and have been treated with adjuvant imatinib for 3 years after surgery will be randomly allocated in a 1:1 ratio to receive imatinib (Gleevec) for 2 more years (Arm A) or to stop imatinib (Arm B). The study participants are required to have histologically verified GIST with a high risk of GIST recurrence despite removal of all macroscopic GIST tissue at surgery and 3 years of adjuvant imatinib. The high risk of GIST recurrence is defined as one of the following: gastric GIST with mitotic count >10/50 high power fields (HPFs) of the microscope, non-gastric GIST with mitotic count >5/50 HPFs, or tumor rupture. Study participants allocated to Arm A will receive imatinib 400 mg/day for 24 months after the date of randomization. All study participants will be followed up using blood tests and computerized tomography (or MRI) of the abdomen. The computerized tomography examinations will be performed at 6 month intervals. A total of 300 patients will be entered to the study. The study hypothesis is that adjuvant imatinib given for a total of 5 years may prevent some of the GISTs to recur as compared to patients who receive adjuvant imatinib for 3 years, and there may be a difference in the rate of GIST recurrence between the two groups.

NCT02413736 Sarcoma
MeSH: Sarcoma
HPO: Sarcoma Soft tissue sarcoma

1 Interventions

Name: Imatinib

Description: Imatinib 400 mg/day

Type: Drug

Imatinib


Primary Outcomes

Description: Time from the date of randomization to GIST recurrence or death.

Measure: Recurrence-free survival

Time: 5 years

Secondary Outcomes

Description: Time from the date of randomization to death.

Measure: Overall survival

Time: 5 years

Description: Time from the date of randomization to the date of death considered to be caused by GIST.

Measure: GIST-specific survival

Time: 5 years

Description: Adverse effects considered to be related to the treatment.

Measure: Adverse effects

Time: 5 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 D842V

- Presence of a substitution mutation at PDGFRA codon D842 (usually D842V). --- D842V ---



HPO Nodes


HPO:
Sarcoma
Genes 197
REST RB1 SDHC KRAS PAX7 ABCA5 ASPSCR1 RECQL4 SUFU APC ANTXR2 FH GREM1 KRT17 EXT1 PIK3CA BMPR1B RASGRP1 KIT SDHD PRKCD REST KCNN3 IDH2 NF1 CTNNB1 PDGFRB CDKN2B KEAP1 DICER1 DICER1 TAF15 CDKN2A FGFR3 SLC22A18 PTCH2 CDKN2C NBN CHEK2 EP300 AXIN2 CHEK2 IFNG PTH1R COL1A1 FOXO1 TBX18 GJC2 FLT4 PRKAR1A DHCR24 MSH2 MLH1 ANTXR2 GNAS CASP10 TRIP13 NUTM1 MDM2 TSC1 PTEN KCNH1 BUB1B FLNA NF2 ELMO2 NF1 BUB3 DCC MEN1 TSC1 MSH2 TP53 PTEN FAM20C PDGFB BUB1 NOTCH3 ATP6V1B2 TSC1 SUFU FLCN WT1 MSH2 MEN1 FH NRAS MTAP APC NF1 CHEK2 NR4A3 NBN APC NF2 TSC2 IL6 SPRED1 AKT1 NRAS BUB1B SOS1 FLCN SDHC SMARCB1 IDH1 LMNA MSH6 SDHC TSC2 NF2 SRC BUB1 APC RECQL4 ABCA5 SDHB GNAS APC PDGFRB VEGFC HRAS KCNH1 FAS BRD4 PRLR DLC1 SDHB PIK3CA WRN TP53 MAP2K1 IDH1 BRAF MLH1 CDKN1A RPS19 FOXC2 EWSR1 PTCH1 APC AKT1 CDKN2A KIT TP53 PDGFB AKT1 MSH6 EWSR1 CDC73 KIT NRAS IDH2 EXT2 CDKN1B SOS1 NF1 KLLN APC TSC2 SSX2 SEC23B DICER1 PIK3CA PDGFRA FAS EXT1 APC RECQL4 HRAS MLH1 CTNNB1 BMPR1A PMS2 EXT2 WRN PTEN SSX1 SDHA PTPN11 SDHB BUB1B PAX3 FASLG GDF5 CEP57 SQSTM1 CDC73 EXT1 TP53 PTPRJ CDKN1B PLCD1 RB1 APC PTCH1 MC1R
Soft tissue sarcoma
Genes 150
REST TSC2 SDHC SPRED1 KRAS PAX7 ABCA5 AKT1 NRAS BUB1B SOS1 FLCN SDHC ASPSCR1 SMARCB1 SUFU APC ANTXR2 MSH6 TSC2 NF2 SRC BUB1 FH APC GREM1 ABCA5 KRT17 APC PIK3CA RASGRP1 SDHD PRKCD REST PDGFRB KCNN3 NF1 VEGFC CTNNB1 HRAS KCNH1 PDGFRB FAS CDKN2B KEAP1 DICER1 DICER1 PRLR DLC1 SDHB PIK3CA FGFR3 SLC22A18 PTCH2 MAP2K1 CDKN2C NBN EP300 AXIN2 BRAF MLH1 CDKN1A IFNG COL1A1 FOXO1 FOXC2 GJC2 FLT4 PRKAR1A PTCH1 DHCR24 APC MSH2 MLH1 AKT1 ANTXR2 CASP10 TP53 TRIP13 TSC1 PDGFB AKT1 PTEN MSH6 CDC73 KIT NRAS KCNH1 BUB1B CDKN1B FLNA SOS1 NF2 ELMO2 NF1 NF1 BUB3 DCC MEN1 TSC1 KLLN MSH2 APC TSC2 TP53 SSX2 SEC23B PTEN DICER1 PIK3CA FAM20C FAS PDGFB APC BUB1 NOTCH3 HRAS ATP6V1B2 MLH1 TSC1 CTNNB1 BMPR1A PMS2 SUFU PTEN FLCN SSX1 PTPN11 SDHB BUB1B MSH2 PAX3 FASLG CEP57 MEN1 FH CDC73 NRAS PTPRJ MTAP APC CDKN1B PLCD1 NF1 APC PTCH1 NBN APC MC1R NF2